Gosselies, Belgium, 14 September 2018, 7 am CEST – BONE THERAPEUTICS (Euronext Brussels and Paris: BOTHE), the bone cell therapy company addressing high unmet medical needs in orthopaedics and bone diseases, today announces positive final results in the Phase I/IIA delayed-union study of its allogeneic bone cell therapy product ALLOB in 21 patients, supporting the future clinical development of the delayed union indication.

The Company also announces the development of an optimized production process for ALLOB, which the Company believes delivers critical improvements in consistency, scalability, cost-effectiveness and ease of use. In order to streamline the progress of ALLOB through late stage clinical trials and towards commercialization, Bone Therapeutics intends to implement this optimized manufacturing process for all future clinical development programmes, including the Phase IIB trial of ALLOB in delayed union fractures.

Trial results

The Phase I/IIA study was a six-month open-label trial to evaluate the safety and efficacy of ALLOB in the treatment of delayed-union fractures of long bones. The study evaluated 21 patients, who each had a fracture that had failed to consolidate after a minimum of three and a maximum of seven months. Each patient received a single percutaneous administration of ALLOB directly into the fracture site and completed a six-month follow-up. Fracture healing of ALLOB-treated patients was assessed using both radiological evaluation (based on CT-scan) and clinical evaluation (e.g. health status and pain).

At six months post administration, 100% of the patients met the primary endpoint, defined as an increase of at least two points on the radiological Tomographic Union Score (TUS) or an improvement of at least 25% of the clinical Global Disease Evaluation (GDE) score vs. baseline.

From a radiological perspective, the patients improved by on average 3.84 points on the TUS score (statistically significant), almost twice the required increase of two points. This minimum two-point increase was achieved by 16 out of 21 patients (76%).

From a clinical perspective, the health status of patients, as measured by the GDE score, improved statistically significantly by on average 48%. The minimum 25% improvement was achieved by 16 out of 21 patients (76%). Pain at the fracture site, an important secondary endpoint, was statistically significantly reduced by on average 61%.

Overall, ALLOB was shown to be well-tolerated and the safety profile was consistent with the interim analysis reported on 20 September 2017. As previously described in the literature covering clinical studies with allogeneic mesenchymal stem cells or their derivatives, it was observed that blood samples of about half of the patients contained donor-specific antibodies, either pre-existing or developed after administration.

Manufacturing update

With its core focus on its off-the-shelf, allogeneic cell therapy platform, Bone Therapeutics has been optimizing its ALLOB manufacturing process in order to improve consistency, scalability, cost effectiveness and ease of use, which are critical for development and commercialisation in cell therapy.

The Company has successfully developed an optimized process that it believes will satisfy these objectives. The optimized production process significantly increases the production yield, generating tens of thousands of doses of ALLOB per bone marrow donation. Additionally, the final ALLOB product will be cryopreserved, enabling easy shipment and the capability to be stored in a frozen form at the hospital level, making it readily available for patients in need. The process will therefore substantially reduce overall production costs, simplify supply chain logistics, improve patient accessibility and facilitate global commercialisation to large patient populations more affordably.

Bone Therapeutics believes the optimized manufacturing process is vital to the future commercial success of ALLOB. In order to avoid process changes in later phases of development, improve cost effectiveness and streamline ALLOB’s route to market, the Company will implement the optimized production process for all future clinical trials with ALLOB, including the planned Phase IIB delayed-union trial.

The Company’s immediate focus is on submitting a new clinical trial application (CTA) with the regulatory authorities to allow the start of a Phase IIB trial in delayed union, utilising the optimized production process. Bone Therapeutics is currently generating the non-clinical data required for the application and expects to submit the CTA for a multi-centre, randomized, controlled study in H2 2019.

Thomas Lienard, Chief Executive Officer of Bone Therapeutics, commented: “The continued positive clinical development progress with ALLOB, highlighted by these results today, paves the way for the next stage of development.”

“In cell therapy, a robust and consistent manufacturing process is critical to successful commercialisation. We are strongly encouraged by the progress we have made in optimising our manufacturing process, delivering a significant improvement which we believe safeguards the quality, consistency and cost-effectiveness of our allogeneic product and will support our future commercialisation strategy.”

“Whilst progressing this unique allogeneic bone cell therapy product to market as quickly as possible remains our top priority, we want to take this opportunity to align our clinical development as closely as possible with our future commercialization strategy. We believe the positive clinical data reported so far for ALLOB and the optimization of our manufacturing process put us in the right position to move forward with the clinical development of our allogeneic platform and achieve a competitive product profile.”

Key opinion leader event

The Company will host a Key Opinion Leader Event in Paris today at 12.30pm CEST. Presentations will be given by Prof. Dr. Frédéric Dubrana, Orthopaedic Surgeon at the University Hospital of Brest and Professor at the University of Western Brittany, alongside Thomas Lienard, Chief Executive Officer. The event in Paris will be held in French with an English language webcast of the same presentations at 3.30pm CEST. For more information please contact investorrelations@bonetherapeutics.com.

Webcast

To access the webcast, please go to the webcast link below. To participate in the Q&A, dial one of the appropriate numbers below quoting the confirmation code:

Belgium:    +32 (0)2 404 0659
France:   +33 (0)1 76 77 22 74
United Kingdom:   +44 (0)330 336 9105
United States:   +1 929-477-0324
Confirmation Code:   4247192

Webcast link: https://edge.media-server.com/m6/p/8ya7dmns

About Bone Therapeutics

Bone Therapeutics is a leading cell therapy company addressing high unmet needs in orthopaedics and bone diseases. Based in Gosselies, Belgium, the Company has a broad, diversified portfolio of bone cell therapy products in clinical development across a number of disease areas targeting markets with large unmet medical needs and limited innovation.

Bone Therapeutics’ technology is based on a unique, proprietary approach to bone regeneration, which turns undifferentiated stem cells into bone-forming cells. These cells can be administered via a minimally invasive procedure, avoiding the need for invasive surgery.

The Company’s primary clinical focus is ALLOB, an allogeneic “off-the-shelf” cell therapy product derived from stem cells of healthy donors, which is in Phase II studies for the treatment of delayed-union fractures and spinal fusion. The Company also has an autologous bone cell therapy product, PREOB, obtained from patient’s own bone marrow and currently in Phase III development for osteonecrosis of the hip.

Bone Therapeutics’ cell therapy products are manufactured to the highest GMP standards and are protected by a rich IP estate covering nine patent families. Further information is available at: www.bonetherapeutics.com.

Contacts

Bone Therapeutics SA
Thomas Lienard, Chief Executive Officer
Jean-Luc Vandebroek, Chief Financial Officer
Tel: +32 (0) 71 12 10 00
investorrelations@bonetherapeutics.com

For Belgium and International Media Enquiries:
Consilium Strategic Communications
Amber Fennell, Jessica Hodgson, Hendrik Thys and Lindsey Neville
Tel: +44 (0) 20 3709 5701
bonetherapeutics@consilium-comms.com

For French Media and Investor Enquiries:
NewCap Investor Relations & Financial Communications
Pierre Laurent, Louis-Victor Delouvrier and Nicolas Merigeau
Tel: + 33 (0)1 44 71 94 94
bone@newcap.eu

For US Media and Investor Enquiries
Westwicke Partners
John Woolford
Tel: + 1 443 213 0506
john.woolford@westwicke.com

Certain statements, beliefs and opinions in this press release are forward-looking, which reflect the Company or, as appropriate, the Company directors` current expectations and projections about future events. By their nature, forward-looking statements involve a number of risks, uncertainties and assumptions that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements. These risks, uncertainties and assumptions could adversely affect the outcome and financial effects of the plans and events described herein. A multitude of factors including, but not limited to, changes in demand, competition and technology, can cause actual events, performance or results to differ significantly from any anticipated development. Forward looking statements contained in this press release regarding past trends or activities should not be taken as a representation that such trends or activities will continue in the future. As a result, the Company expressly disclaims any obligation or undertaking to release any update or revisions to any forward-looking statements in this press release as a result of any change in expectations or any change in events, conditions, assumptions or circumstances on which these forward-looking statements are based. Neither the Company nor its advisers or representatives nor any of its subsidiary undertakings or any such person`s officers or employees guarantees that the assumptions underlying such forward-looking statements are free from errors nor does either accept any responsibility for the future accuracy of the forward-looking statements contained in this press release or the actual occurrence of the forecasted developments. You should not place undue reliance on forward-looking statements, which speak only as of the date of this press release.

PLAINSBORO, N.J., Sept. 10, 2018 (GLOBE NEWSWIRE) — Integra LifeSciences Holdings Corporation (Nasdaq:IART), a leading global medical technology company, today announced it has been selected as a primary provider for cellular-based tissue products within Healogics^® Inc. new iSupply program. This program is exclusively available to Healogics’ hospital partners and is focused on ensuring hospitals and patients receive the best value from wound care products commonly used in Wound Care Centers^® and other sites of care.

Under Healogics new iSupply program, Integra will be a lead provider for cellular-based tissue products – AmnioExcel^® Amniotic Allograft Membrane, AMNIOMATRIX^® Amniotic Allograft Suspension, PriMatrix^® Dermal Repair Scaffold, PriMatrix^® Ag Antimicrobial Dermal Repair Scaffold for the treatment of acute and chronic complex wounds, and Omnigraft^® Dermal Regeneration Matrix for the treatment of diabetic foot ulcers. Cellular-based tissue products or skin substitutes are a group of FDA-regulated products that are designed to repair, restore or replace dermal and epidermal tissue architecture through different mechanisms of action. Integra’s comprehensive suite of evidence-based product solutions are designed to support the body’s natural restorative healing process.  In addition, Integra’s market leading total contact casting system, TCC-EZ^® for offloading and protection of wounds, will also be available under the iSupply program.

“We are excited to be a primary provider of cellular-based tissue products for the iSupply program,” said Robert T. Davis, Jr., corporate vice president and president, Orthopedics and Tissue Technologies.  “Integra’s products were selected through a rigorous analysis of published data and reviewed by Healogics’ value analysis committee of leading wound care clinicians.  This partnership with Healogics reinforces Integra’s commitment to broader access to our advanced wound care products and improving outcomes for patients with chronic wounds.”

“I have used Integra’s line of advanced wound care products and believe they are a vital part of our iSupply Program,” said Dr. Scott Covington, executive vice president of Provider Education at Healogics.  “Through this program, we are able to offer high quality, cost-effective products to clinicians, who can confidently use these products to care for their patients.”

About Integra
Integra LifeSciences is a global leader in regenerative technologies, neurosurgical and extremity orthopedic solutions dedicated to limiting uncertainty for clinicians, so they can focus on providing the best patient care. Integra offers a comprehensive portfolio of high quality, leadership brands that include AmnioExcel^®, Bactiseal^®, Cadence^®, Certas™, Codman^®, CUSA^®, DuraGen^®, DuraSeal^®, ICP Express^®, Integra^®, MediHoney^®, MicroFrance^®, PriMatrix^®, Salto Talaris^®, SurgiMend^®, TCC-EZ^®, Titan™ and VersaTru™.  For the latest news and information about Integra and its brands, please visit www.integralife.com.

This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include, but are not limited to, statements concerning the products and services provided by Integra. Such forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from predicted or expected results. Among other things, the willingness of surgical professionals to use Integra products may affect the prospects for their use in surgical procedures. In addition, the economic, competitive, governmental, technological and other factors, identified under the heading “Risk Factors” included in Item IA of Integra’s Annual Report on Form 10-K for the year ended December 31, 2017 and information contained in subsequent filings with the Securities and Exchange Commission could affect actual results.

About Healogics
Headquartered in Jacksonville, Fla., Healogics is the nation’s wound healing expert. Last year over 330,000 patients received advanced wound care through a nationwide network of 700 Wound Care Centers^®. The Healogics team is made up of nearly 3,000 employees, 4,000 affiliated physicians and a Healogics Specialty Physician practice group of almost 300. In addition to the company’s network of outpatient Centers, Healogics partners with over 300 skilled nursing facilities to care for patients with chronic wounds, and provides inpatient consults at 85 partner hospitals. As the industry leader, Healogics has the largest repository of chronic wound-specific patient data in the country. The Healogics Wound Science Initiative, an effort launched in 2017 to provide peer-reviewed research, recognizes the value and relevance of big data and advanced analytics to drive continuous, collaborative learning towards a better understanding of how to efficiently utilize healthcare resources for patients with wounds. For additional information, please visit Healogics.com.

CONTACT: Integra LifeSciences Holdings Corporation

Investors
Sravan Emany
(609) 936-2488
sravan.emany@integralife.com

Michael Beaulieu
609-750-2827
michael.beaulieu@integralife.com

Media 
Laurene Isip
609-750-7984
laurene.isip@integralife.com

Healogics Media Contact
Leslie Niblock
904-524-2695
leslie.niblock@healogics.com

WALTHAM, Mass., Sept. 05, 2018 (GLOBE NEWSWIRE) — Histogenics Corporation (Histogenics) (Nasdaq: HSGX), a leader in the development of restorative cell therapies that may offer rapid-onset pain relief and restored function, today announced that its Phase 3 clinical trial of NeoCart did not meet the primary endpoint of a statistically significant improvement in pain and function in a dual threshold responder analysis one year after treatment as compared to microfracture.  In the modified Intent to Treat (mITT) population (which excludes those patients who were randomized but not treated with NeoCart), 74.2% of the NeoCart patients exhibited clinically meaningful improvements in pain and function compared to 62.0% of microfracture patients at one year (p=0.071).  However, in this mITT population, patients treated with NeoCart achieved a statistically significant improvement in pain and function (p=0.018) six months after treatment as compared to patients treated with microfracture.  Both NeoCart and microfracture were well tolerated and exhibited strong safety profiles.

“Based on the totality of the data generated in the Phase 3 clinical trial, we continue to believe in NeoCart’s potential as a treatment for knee cartilage damage.  When we designed our Phase 3 clinical trial in 2009, we set a very high clinical bar for NeoCart and narrowly missed hitting the trial’s primary endpoint with statistical significance by only two microfracture responders out of the 249 patients that participated in the trial.  While the NeoCart treatment group exhibited a response as early as three months after treatment that continued through two years, the microfracture response rate was better than expected, which impacted the statistics.  We are encouraged by the results and believe we have a meaningfully differentiated product that, if approved, can compete effectively and provide physicians and patients with a beneficial treatment option that may grow the market,” said Adam Gridley, President and Chief Executive Officer of Histogenics.  “We continue to analyze the data and are in the process of scheduling a meeting with the FDA to discuss the results and prepare for a potential submission of a biologics license application for NeoCart.  We wish to acknowledge and thank the patients and investigators who participated in the trial and shared their positive experiences with NeoCart,” stated Mr. Gridley.

The NeoCart Phase 3 clinical trial is believed to be the largest and first prospectively designed, randomized clinical trial in North America evaluating the safety and efficacy of a restorative cell therapy to treat knee cartilage damage.  It is also believed to be the only trial with a dual threshold responder analysis endpoint.  As part of the prospective data analysis, Histogenics collected a variety of patient reported outcome endpoints, including all measures of the Knee Injury and Osteoarthritis Outcomes Score (KOOS) and the International Knee Documentation Committee (IKDC) score, which are validated, patient-centered assessments of pain and function that are commonly used in current clinical trials of cartilage therapies.  On all but one of these measures, two of which are being utilized as primary endpoints in ongoing clinical trials by third parties in the U.S. for other therapies, NeoCart demonstrated statistically significant superiority versus microfracture at one and two years.

The Phase 3 clinical trial is the first study prospectively enrolled consistent with current U.S. Food and Drug Administration (FDA) guidance, which provides for the use of microfracture as a comparator treatment in trials to repair knee cartilage damage.  The published FDA guidance also specifically calls for a study population that, given the clinical limitations and variable results of microfracture, we believe provides more favorable results than what is typically seen in microfracture in both the literature and a real-world setting.

“We are pleased with the overall performance of NeoCart in this Phase 3 clinical trial and the data confirm the feedback we have received from several of the investigators who participated in the trial.  Most importantly, patients treated with NeoCart displayed an early and sustained recovery from pain and return to function that was clinically meaningful.  The data from this trial are also consistent with results seen in prior clinical trials of NeoCart as well as the biomechanical data generated as part of our collaboration with Cornell University,” said Lynne Kelley, M.D., Chief Medical Officer of Histogenics.  “While we are continuing to analyze the data, we have already seen a number of important results, including a statistically significant improvement of NeoCart compared to microfracture in lesion sizes of greater than 2 cm and patients with higher body mass index.  We think that results such as these will be an important part of our planned discussions with the FDA, as well as with clinicians if NeoCart is approved,” continued Dr. Kelley.

There are approximately 1.2 million arthroscopic procedures conducted each year to treat knee cartilage defects in the U.S., with less than half of eligible patients currently electing to receive treatment.  Based on the data generated to date, NeoCart may offer many of these patients a safe and effective alternative, subject to FDA approval.

“As a physician who treats patients with knee cartilage damage, I am keenly aware of the limitations of current treatment approaches for this common and underserved condition,” said David C. Flanigan, MD Associate Professor, Department of Orthopedics, Director, Cartilage Restoration Program at The Ohio State University Wexner Medical Center, and a high-enrolling investigator in the Phase 3 clinical trial.  “The pain and loss of function associated with uncorrected knee cartilage lesions can significantly limit these patients’ ability to maintain their daily routines and often leads to other more serious comorbidities over time.  The rapid recovery for patients who received this cartilage tissue implant compared to those who underwent microfracture indicates that implants, such as NeoCart, may be an attractive alternative for patients seeking a better quality of life and faster return to function,” continued Dr. Flanigan.

The primary endpoint for the Phase 3 clinical trial was a dual-threshold responder analysis measuring the improvement in KOOS pain and IKDC function scores for each patient treated with NeoCart compared to those treated with microfracture one year after the time of treatment.  Dual-threshold responders were defined as patients who, relative to their baseline measurements, had at least a 12-point improvement in the KOOS pain sub-score assessment and a 20-point improvement in the IKDC subjective assessment.  The trial also evaluated additional pain, quality of life, and function outcomes using all five measures of KOOS subscales, including Sports and Recreation.  The change from baseline and the relative change between the NeoCart and microfracture arms was also measured at one year which contrasts with clinical trials of other products, either on the market or in development, that measured these changes at two years.  Efficacy and safety will continue to be followed out to three years, and Histogenics expects to further track patients for future planned analyses, including patients from prior clinical trials who received a NeoCart treatment.

Demographics for both study arms were similar and represent a patient population that was intended to ensure that microfracture would respond favorably, including patients with an average age of approximately 39 years old and a Body Mass Index (BMI) of approximately 27.  Furthermore, the mean lesion size was 2.1 cm in the NeoCart arm and 1.8 cm in the microfracture arm.  There were no other significant differences between the treatment arms.

The results with respect to the primary endpoint (dual threshold responder analysis one year after treatment) are summarized below:

	NeoCart		Microfracture
	Positive Responders	Responder Rate	Positive Responders	Responder Rate	Difference
ITT	121/170	71.2%	49/79	62.0%	9.2	p=0.1877
mITT	121/163	74.2%	49/79	62.0%	12.2	P=0.0714
As Treated	120/162	74.1%	50/80	62.5%	11.6	p=0.0735
Per Protocol	118/155	76.1%	43/65	66.2%	10.0	p=0.1362

Key additional findings from the clinical trial include:

NeoCart demonstrated statistically significant improvements in pain and function at both one and two years after treatment as measured by changes in the KOOS and IKDC scores.

KOOS pain score (mITT Population)
Change from Baseline
(NeoCart Baseline = 54.0; Microfracture Baseline = 52.4)
	NeoCart		Microfracture
Visit	N	Mean	N	Mean	P-Value
3-months	160	24.1	75	22.4	0.0487*
6-months	157	28.6	75	27.0	0.0819
1-year	158	31.4	72	28.7	0.0239*
2-years	87	32.2	34	28.9	0.0080*
3-years	39	34.3	16	30.7	0.1071
* Statistically significant

IKDC subjective knee exam score (mITT Population)
Change from Baseline
(NeoCart Baseline = 40.3; Microfracture Baseline = 40.0)
	NeoCart		Microfracture
Visit	N	Mean	N	Mean	P-Value
3-months	159	13.7	76	14.5	0.9686
6-months	156	24.4	74	22.4	0.1572
1-year	158	33.1	71	28.3	0.0126*
2-years	87	35.3	34	30.2	0.0366*
3-years	38	39.9	16	32.6	0.2691
* Statistically significant

NeoCart, the most advanced therapy from Histogenics restorative cell therapy platform, is functional cartilage that combines breakthroughs in bio-engineering, biomaterials and cell processing to enhance the autologous cartilage repair process.  NeoCart, which is one of the most rigorously studied restorative cell therapies for orthopedic use, merges a patient’s own cells with a fortified three-dimensional scaffold designed to accelerate healing and reduce pain.  NeoCart’s ability to function like cartilage at the time of treatment may enable patients to return to work and daily activities more rapidly than currently available treatment options such as microfracture.

Histogenics is in the process of requesting a meeting with the FDA to discuss the data and a potential BLA submission.  In addition, Histogenics intends to present the complete study results at upcoming medical conferences and will seek to have the data published in one or more peer reviewed journals.

Conference Call and Webcast Information

Histogenics management will host a conference call on Wednesday, September 5, 2018 at 8:30am EDT.  A question-and-answer session will follow Histogenics’ remarks.  To participate on the live call, please dial  (877) 930-8064 (domestic) or (253) 336-8040 (international) and provide the conference ID 8764946 five to ten minutes before the start of the call.

To access a live audio webcast of the presentation on the “Investor Relations” page of the Histogenics website, please click here. A replay of the webcast will be archived on Histogenics’ website for approximately 60 days following the presentation.

About Histogenics Corporation

Histogenics (Nasdaq:  HSGX) is a leader in the development of restorative cell therapies that may offer rapid-onset pain relief and restored function.  Histogenics’ lead investigational product, NeoCart, is designed to rebuild a patient’s own knee cartilage to treat pain at the source and potentially prevent a patient’s progression to osteoarthritis.  NeoCart is one of the most rigorously studied restorative cell therapies for orthopedic use.  NeoCart is designed to perform like articular hyaline cartilage at the time of treatment, and as a result, may provide patients with more rapid pain relief and accelerated recovery as compared to the current standard of care. Histogenics’ technology platform has the potential to be used for a broad range of additional restorative cell therapy indications.  For more information on Histogenics and NeoCart, please visit www.histogenics.com.

Forward-Looking Statements

Various statements in this release are “forward-looking statements” under the securities laws.  Words such as, but not limited to, “anticipate,” “believe,” “can,” “could,” “expect,” “estimate,” “design,” “goal,” “intend,” “may,” “might,” “objective,” “plan,” “predict,” “project,” “target,” “likely,” “should,” “will,” and “would,” or the negative of these terms and similar expressions or words, identify forward-looking statements.  Forward-looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions and uncertainties.

Important factors that could cause actual results to differ materially from those reflected in Histogenics’ forward-looking statements include, among others:  NeoCart’s potential as a treatment for knee cartilage damage; expectations regarding the timing and success of discussions with the FDA regarding the submission of a biologics license application for NeoCart; the timing, associated expenses and ability to obtain and maintain regulatory approval of NeoCart or any product candidates, and the labeling for any approved products; the market size and potential patient population in markets where Histogenics’ and its partners expect to compete; updated or refined data based on Histogenics’ continuing review and quality control analysis of clinical data; the scope, progress, timing, expansion, and costs of developing and commercializing Histogenics’ product candidates; the ability to obtain and maintain regulatory approval regarding the comparability of critical NeoCart raw materials following its technology transfer and manufacturing location transition; Histogenics’ expectations regarding its expenses and revenue; Histogenics’ ability to obtain additional debt or equity capital and other factors that are described in the “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of Histogenics’ Annual Report on Form 10-K for the year ended December 31, 2017 and Quarterly Report on Form 10-Q for the quarter ended June 30, 2018, which are on file with the SEC and available on the SEC’s website at www.sec.gov.  In addition to the risks described above and in Histogenics’ Annual Report on Form 10-K and Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the SEC, other unknown or unpredictable factors also could affect Histogenics’ results.

There can be no assurance that the actual results or developments anticipated by Histogenics will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on, Histogenics.  Therefore, no assurance can be given that the outcomes stated in such forward-looking statements and estimates will be achieved.

All written and verbal forward-looking statements attributable to Histogenics or any person acting on its behalf are expressly qualified in their entirety by the cautionary statements contained or referred to herein.  Histogenics cautions investors not to rely too heavily on the forward-looking statements Histogenics makes or that are made on its behalf.  The information in this release is provided only as of the date of this release, and Histogenics undertakes no obligation, and specifically declines any obligation, to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise.

Contacts:
Investor Relations:
Tel: +1 (781) 547-7909


Media Relations:
Glenn Silver, Lazar Partners Ltd.
Tel: + 1 (646) 871-8485

September 05, 2018

MARIETTA, Ga., Aug. 24, 2018 /PRNewswire/ — MiMedx Group, Inc. (NASDAQ : MDXG ), a leading developer and marketer of regenerative and therapeutic biologics, today announced that a new study regarding the use of EpiFix® in the treatment of diabetic foot ulcers (DFUs) has been published in the peer-reviewed journal, International Wound Journal.

The paper is entitled “A Confirmatory Study on the Efficacy of Dehydrated Human Amnion/Chorion Membrane dHACM Allograft in the Management of Diabetic Foot Ulcers: A Prospective, Multicenter, Randomized, Controlled Study of 110 Patients from 14 Wound Clinics.” The paper was authored by: William Tettelbach, MD; Shawn Cazzell, DPM; Alexander M. Reyzelman, DPM; Felix Sigal, DPM; Joseph M Caporusso, DPM; and Patrick S. Agnew, DPM. The electronic publication of the article in International Wound Journal can be found at https://onlinelibrary.wiley.com/doi/full/10.1111/iwj.12976.

This multi-center randomized and controlled trial was led by William Tettelbach, MD, principal investigator and former Executive System Medical Director of Wound Care and Hyperbaric Medicine Services for InterMountain Healthcare. Dr. Tettelbach is now Associate Chief Medical Officer for MiMedx, a position that postdated the completion of the study.

Clinical Study Design and Results

The objective of the study was to determine the safety and effectiveness of EpiFix as compared to standard of care (SOC) therapy for the treatment of non-healing DFUs. The primary efficacy endpoint was the incidence of complete wound closure over a 12-week period. Data from 110 patients meeting study inclusion and exclusion criteria were analyzed in the Intent-to-Treat (ITT) cohort. A total of 98 patients completed the study Per Protocol (Per-Protocol cohort).

ITT analysis requires patients to be included even if they did not fully adhere to the protocol. In comparison, in a Per-Protocol analysis, only patients who completed the entire clinical trial according to the protocol are counted towards the final results.

In the current study on an ITT basis, 70% of patients who received weekly EpiFix had complete healing by 12 weeks versus 50% of patients only receiving weekly SOC (EpiFix 70% vs. SOC 50%, p=0.0338).

For patients completing the study per protocol, 81% of those who received weekly EpiFix treatments achieved complete healing by 12 weeks. In comparison, 55% of patients had complete healing in 12 weeks after receiving weekly SOC alone (EpiFix + SOC 81% vs. SOC 55%, p=0.0093).

In the ITT cohort, adjusting for co-variates associated with healing, Cox regression analysis showed patients treated with EpiFix were more than twice as likely to heal completely within 12 weeks as those not receiving EpiFix  (HR: 2.15, 95% confidence interval 1.30-3.57, p=0.003).

Mechanism of Action     

EpiFix® is a tissue matrix allograft composed of dehydrated human amnion/chorion membrane (dHACM). The Company’s published scientific work indicates that MiMedx dHACM retains a diverse array of regulatory proteins including essential growth factors, cytokines and chemokines, which are regulators in inflammation, wound repair and tissue regeneration.

About MiMedx 

MiMedx® is a leading biopharmaceutical company developing and marketing regenerative and therapeutic biologics utilizing human placental tissue allografts with patent-protected processes for multiple sectors of healthcare. “Innovations in Regenerative Medicine” is the framework behind the Company’s mission to provide physicians products and tissues to help the body heal itself. The Company processes the human placental tissue utilizing its proprietary PURION® Process methodology, among other processes, to produce allografts by employing aseptic processing techniques in addition to terminal sterilization. MiMedx has supplied over 1.3 million allografts to date for application in the Wound Care, Burn, Surgical, Orthopedic, Spine, Sports Medicine, Ophthalmic and Dental sectors of healthcare. For additional information, please visit www.mimedx.com.

Safe Harbor Statement

This press release includes forward-looking statements. Statements regarding the safety and efficacy of EpiFix are forward-looking statements. Additional forward-looking statements may be identified by words such as “believe,” “expect,” “may,” “plan,” “potential,” “will,” “preliminary,” and similar expressions, and are based on management’s current beliefs and expectations. Forward-looking statements are subject to risks and uncertainties, and the Company cautions investors against placing undue reliance on such statements.

Actual results may differ materially from those set forth in the forward-looking statements. For more detailed information on the risks and uncertainties, please review the Risk Factors section of the Company’s most recent annual report or quarterly report filed with the Securities and Exchange Commission.  Any forward-looking statements speak only as of the date of this press release and the Company assumes no obligation to update any forward-looking statement.

SOURCE MiMedx Group, Inc.

Related Links

http://www.mimedx.com

BELGRADE, MT, Aug. 20, 2018 (GLOBE NEWSWIRE) — Xtant Medical Holdings, Inc. (NYSE American: XTNT), a leader in the development and commercialization of regenerative medicine products and medical devices, today announced the appointment of Kathie Lenzen as chief financial officer, effective August 20, 2018. Ms. Lenzen will report to Carl O’Connell, Xtant’s chief executive officer.

“Ms. Lenzen is an accomplished healthcare executive with significant financial expertise and we are pleased that she is joining our executive management team,” said Carl O’Connell. “In addition to the financial leadership she will provide to the organization, she is a strong strategic, cross-functional leader. Her appointment continues our commitment to building a highly skilled management team.”

Kathie Lenzen brings over 36 years of financial experience to Xtant. Most recently, Ms. Lenzen served as the senior vice president and general manager of Astora Women’s Health division. Prior to being in this position, she was the vice president of finance for American Medical Systems and drove financial performance to ensure EBITDA growth consistently outpaced revenue growth. She is versed in cross-departmental collaboration from a financial perspective, knowledgeable about information systems, restructuring for profitability, and merger and acquisition activities.

“I am excited to join the Xtant team and contribute to the Company’s growth strategy,” said Kathie Lenzen. “Xtant has made considerable progress over the past year, and I look forward to helping the Company continue to transform its business and drive shareholder value.”

About Xtant Medical

Xtant Medical develops, manufactures and markets regenerative medicine products and medical devices for domestic and international markets. Xtant Medical products serve the specialized needs of orthopedic and neurological surgeons, including orthobiologics for the promotion of bone healing, implants and instrumentation for the treatment of spinal disease, tissue grafts for the treatment of orthopedic disorders, and biologics to promote healing following cranial, and foot and ankle surgeries. With core competencies in both biologic and non-biologic surgical technologies, Xtant Medical can leverage its resources to successfully compete in global neurological and orthopedic surgery markets. For further information, please visit www.xtantmedical.com.

Important Cautions Regarding Forward-looking Statements

This press release contains certain disclosures that may be deemed forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements that are predictive in nature, that depend upon or refer to future events or conditions, or that include words such as ‘‘continue,’’ ‘‘expects,’’ ‘‘anticipates,’’ ‘‘intends,’’ ‘‘plans,’’ ‘‘believes,’’ ‘‘estimates,’’ ‘‘strategy,’’ ‘‘will,’’ “can” or similar expressions or the negative thereof. Statements of historical fact also may be deemed to be forward-looking statements. The Company cautions that these statements by their nature involve risks and uncertainties, and actual results may differ materially depending on a variety of important factors, including, among others: the ability to increase revenue; the ability to achieve expected results; the ability to remain competitive; the ability to innovate and develop new products; the ability to engage and retain qualified personnel; government and third-party coverage and reimbursement for Company products; the ability to obtain and maintain regulatory approvals; government regulations; product liability claims and other litigation to which we may be subjected; product recalls and defects; timing and results of clinical studies; the ability to obtain and protect Company intellectual property and proprietary rights and operate without infringing the rights of others; the ability to service Company debt and comply with debt covenants; the ability to raise additional financing and other factors. Additional risk factors are listed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2017 filed with the Securities and Exchange Commission (SEC) on April 2, 2018 and subsequent SEC filings by the Company, including without limitation its most recent Quarterly Report on Form 10-Q for the quarter ended June 30, 2018. Investors are encouraged to read the Company’s filings with the SEC, available at www.sec.gov, for a discussion of these and other risks and uncertainties. The Company undertakes no obligation to release publicly any revisions to any forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events, except as required by law. All forward-looking statements attributable to us or persons acting on our behalf are expressly qualified in their entirety by this cautionary statement.

SOURCE: Xtant Medical Holdings, Inc.

Company Contact

Xtant Medical
Molly Mason
mmason@xtantmedical.com
Xtant Medical Holdings, Inc.

Lund, Sweden, 18:00 CET, 16 August 2018 – BONESUPPORT™, an emerging leader in orthobiologics for the management of bone voids, announces that its antibiotic-eluting product CERAMENT G has been approved by Health Canada.

CERAMENT G is the first and only CE-marked gentamicin-eluting injectable ceramic bone graft substitute on the market.  CERAMENT G sales have been growing strongly based on the clinical benefits it delivers when used for indications where infection may be present or of concern.

BONESUPPORT is currently conducting the FORTIFY trial to assess CERAMENT G’s ability to improve on the standard-of-care management of patients with open fractures of the tibial diaphysis. The primary endpoints of the trial  include the absence of deep infection at the fracture site and the lack of secondary procedures intended to promote fracture union.  The trial will also evaluate the safety of CERAMENT G in these patients. The trial will enroll up to 230 patients at up to 30 centers in the US and Europe.

Positive data from the FORTIFY trial will be used to support BONESUPPORT’s PMA (Premarket Approval) filing for CERAMENT G   in the US, where the product is expected to be launched in 2021. 

Emil Billbäck, CEO of BONESUPPORT said: “We are looking forward to commercializing CERAMENT G in Canada following its approval by Health Canada. CERAMENT G will be the first injectable antibiotic eluting ceramic bone graft substitute to be launched on the Canadian market. We are currently in dialogue with potential distributors to assist us in bringing this novel product to orthopedic surgeons managing bone voids where infection is present or an important risk.”

About BONESUPPORT™

BONESUPPORT is an innovative and rapidly growing commercial stage orthobiologics company, based in Lund, Sweden. The Company develops and commercializes innovative injectable bio-ceramic bone graft substitutes that remodel to the patient’s own bone and have the capability of eluting drugs directly into the bone void.

BONESUPPORT’s bio-ceramic bone graft substitutes CERAMENT® BONE VOID FILLER (BVF), CERAMENT® G* and CERAMENT® V* are all based on the Company’s novel and proprietary technology platform.

The Company’s products are targeting a large addressable market opportunity across trauma, chronic osteomyelitis (bone infection), revision arthroplasty (replacement of a joint prosthesis), ortho-oncology, foot and ankle, and infected diabetic foot.

BONESUPPORT’s total sales increased from SEK 62 million in 2015 to SEK 129 million in 2017, representing a compound annual growth rate of 45%.

The Company’s research and development is focused on the continuing development and refinement of its CERAMENT technology to extend its use into additional indications by the elution of drugs and therapeutic agents. The Company currently has a pipeline of pre-clinical product candidates that have been designed to promote bone growth.

In addition, BONESUPPORT is looking at opportunities to expand its product offering in the US and has entered into a strategic agreement with MTF Biologics and Collagen Matrix Inc. to market and distribute products that are complementary to CERAMENT BVF.

BONESUPPORT is listed on Nasdaq Stockholm and trades under the ticker “BONEX” (ISIN code: SE0009858152). Further information is available at www.bonesupport.com

*CERAMENT G: Not available in the United States, for investigational use only.
CERAMENT V: Not available in the United States.

BONESUPPORT™ and CERAMENT® are registered trademarks.

For more information contact:

 

BONESUPPORT AB

Emil Billbäck, CEO

+46 (0) 46 286 53 70

 

Björn Westberg, CFO

+46 (0) 46 286 53 60

ir@bonesupport.com

 

Citigate Dewe Rogerson

Pip Batty, David Dible, Shabnam Bashir

+44 (0)20 7282 1022

bonesupport@citigatedewerogerson.com

This information is such information as BONESUPPORT HOLDING AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, at 18.00 CET on 16 August 2018.

 

Pip Batty

Account Manager

 

3 London Wall Buildings

London Wall

London EC2M 5SY

Tel: +44 (0)20 7282 1022

Mob: +44 (0)7808 642 922

Lund, Sweden, 08:00am CET, 2 August 2018 – BONESUPPORT™, an emerging leader in orthobiologics for the management of bone voids, has signed an agreement with MTF Biologics, the world’s largest tissue bank, to extend and strengthen its US product offering.

The agreement will give BONESUPPORT US rights to two forms of bone graft materials comprised of 100% demineralized bone matrix (DBM), which offer improved osteoinductivity when compared to many other DBM products. These products, which are both osteoinductive and osteoconductive, complement CERAMENT BVF (osteoconductive) and the products gained from the Company’s recent strategic agreement with Collagen Matrix Inc. (osteoinductive and osteogenic)

BONESUPPORT plans to launch the products supplied by MTF Biologics under the BONESUPPORT brand name and through its own US distribution network.

MTF Biologics is a non-profit service organization dedicated to providing clinically sound, safe allograft tissue. MTF Biologics is comprised of a national consortium of academic medical institutions, organ procurement organizations and tissue recovery organizations. It is based in Edison, NJ, USA.

Emil Billbäck, CEO of BONESUPPORT said, “Today’s deal with MTF Biologics is a further important step in creating the broad and complementary US product offering that will address the needs of orthopedic surgeons managing bone voids. We are pleased that MTF Biologics, the world’s leading tissue bank, has chosen to partner with BONESUPPORT, and we look forward to marketing products based on their high-quality demineralized bone matrix. With our expanded product portfolio and new broad US distribution channel, that we are on track to have in place in late October, we are well placed to significantly improve our competitive position and rapidly grow sales ahead of the planned US launch of CERAMENT G in 2021.”

“MTF Biologics is pleased to be partnering with BONESUPPORT on the promotion of our demineralized bone matrix fiber technology. We are excited for this opportunity to work together to deliver biologic solutions that serve the needs of surgeons and their patients.” said Tom Shaffer, MTF Biologics EVP, Global Sales & Marketing.

For more information contact:

Emil Billbäck, CEO

+46 (0) 46 286 53 70

Björn Westberg, CFO

+46 (0) 46 286 53 60

ir@bonesupport.com

Citigate Dewe Rogerson

Pip Batty, David Dible, Shabnam Bashir

+44 (0)20 7282 1022

bonesupport@citigatedewerogerson.com

About MTF Biologics

MTF Biologics is a nonprofit organization based in Edison, N.J. It is a national consortium comprised of leading organ procurement organizations, tissue recovery organization and academic medical institutions, and governed by a board of surgeons who are leading experts in tissue transplantation. As the world’s largest tissue bank, MTF Biologics saves and heals lives by honoring donated gifts, serving patients and advancing science. Since its inception in 1987, the organization has received tissue from more than 120,000 donors and distributed more than 7.5 million allografts for transplantation. Through its IIAM subsidiary, it has placed more than 55,000 non-transplantable organs for research. Through its Statline subsidiary, it has managed more than 10 million donor referrals.

For more information, visit www.mtf.org.

About BONESUPPORT™

BONESUPPORT is an innovative and rapidly growing commercial stage orthobiologics company, based in Lund, Sweden. The Company develops and commercializes innovative injectable bio-ceramic bone graft substitutes that remodel to the patient’s own bone and have the capability of eluting drugs directly into the bone void.

BONESUPPORT’s bio-ceramic bone graft substitutes CERAMENT® BONE VOID FILLER (BVF), CERAMENT® G* and CERAMENT® V* are all based on the Company’s novel and proprietary technology platform.

The Company’s products are targeting a large addressable market opportunity across trauma, chronic osteomyelitis (bone infection), revision arthroplasty (replacement of a joint prosthesis) and infected diabetic foot.

BONESUPPORT’s total sales increased from SEK 62 million in 2015 to SEK 129 million in 2017, representing a compound annual growth rate of 45%.

The Company’s research and development is focused on the continuing development and refinement of its CERAMENT technology to extend its use into additional indications by the elution of drugs and therapeutic agents. The Company currently has a pipeline of pre-clinical product candidates that have been designed to promote bone growth.

In addition, BONESUPPORT is looking to expand its product offering in the US and has entered into strategic agreements with Collagen Matrix Inc. and MTF Biologics to market and distribute products that are complementary to CERAMENT BVF.

BONESUPPORT is listed on Nasdaq Stockholm and trades under the ticker “BONEX” (ISIN code: SE0009858152). Further information is available at www.bonesupport.com

*CERAMENT G: Not available in the United States, for investigational use only.
CERAMENT V: Not available in the United States.

BONESUPPORT™ and CERAMENT® are registered trademarks.

This information is such information as BONESUPPORT HOLDING AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, at 08.00 CET on 2 August 2018.