News – Page 51 – Selby Spine

LONDON, July 25, 2018 /PRNewswire/ — Smith & Nephew (LSE: SN, NYSE: SNN), the global medical technology business, announced positive clinical results concerning its JOURNEY™ II Bi-Cruciate Stabilized (BCS) knees. These results suggest JOURNEY II BCS is associated with significant healthcare economic benefits in patients implanted with this device compared to other knee systems.

In a retrospective cohort study from the Premier Perspective Database¹, JOURNEY II BCS patients exhibited lower mean hospital stays and overall reduced mean costs when compared to other knee patients. When comparing 1,692 JOURNEY II BCS patients to the same number of other comparable knee patients, data revealed JOURNEY II BCS patients were:

51% less likely to be readmitted to the hospital within 30 days;
35% more likely to be discharged to their home; and
41% less likely to be discharged to a skilled nursing facility for further care.

The results also showed patients with JOURNEY II BCS experienced statistically significantly reduced length of stay and reduced hospital costs, equivalent to approximately 10% in savings to the overall procedure cost ($16,187 vs. $17,877).

Andy Weymann MD, Chief Medical Officer of Smith & Nephew, commented: “To have a knee system that improves patient outcomes while reducing healthcare costs is a tremendous feat for Smith & Nephew. When we introduced the JOURNEY II Knee System, we wanted to build upon our 150+ years of supporting healthcare professionals and patients in a way that addressed the market where patient outcome measures go beyond implant survivorship. We know hospitals and healthcare professionals have a wide choice in knee implants and this new retrospective analysis supports our view that JOURNEY II BCS is the leading knee platform available in today’s market.”

The Premier Perspective Database study is not the only recent evidence reporting improved patient outcomes with the JOURNEY II BCS Knee System. In another multi-center study published in Techniques in Orthopaedics, JOURNEY II BCS patients demonstrated a smoother recovery, improved function and increased patient satisfaction.^2-6Specifically, study patients implanted with JOURNEY II BCS had 23 degrees more flexion than patients implanted with another comparable knee system along with significantly improved mean knee society scores (89 vs 81; p<0.001) at 1 year follow-up.²

“Every knee product we manufacture is designed to improve patient outcomes while decreasing hospital costs. It is rewarding to see JOURNEY II BCS patients demonstrating a smoother recovery^1-2 and higher patient satisfaction than what we have seen in the past. These outcomes illustrate the value that Smith & Nephew constantly strives to provide to our healthcare system,” Brad Cannon, Chief Marketing Officer.

The JOURNEY II BCS is a member of the JOURNEY II Total Knee Arthroplasty (TKA) system, which also includes JOURNEY II Cruciate Retaining (CR) and the recently launched bi-cruciate retaining JOURNEY II XR.

About Smith & Nephew

Smith & Nephew is a global medical technology business dedicated to helping healthcare professionals improve people’s lives. With leadership positions in Orthopaedic Reconstruction, Advanced Wound Management, Sports Medicine and Trauma & Extremities, Smith & Nephew has around 15,000 employees and a presence in more than 100 countries. Annual sales in 2017 were almost $4.8 billion. Smith & Nephew is a member of the FTSE100 (LSE:SN, NYSE:SNN).

For more information about Smith & Nephew, please visit our website www.smith-nephew.com, follow @SmithNephewplc on Twitter or visit SmithNephewplc on Facebook.com

Forward-looking Statements

This document may contain forward-looking statements that may or may not prove accurate. For example, statements regarding expected revenue growth and trading margins, market trends and our product pipeline are forward-looking statements. Phrases such as “aim”, “plan”, “intend”, “anticipate”, “well-placed”, “believe”, “estimate”, “expect”, “target”, “consider” and similar expressions are generally intended to identify forward-looking statements. Forward-looking statements involve known and unknown risks, uncertainties and other important factors that could cause actual results to differ materially from what is expressed or implied by the statements. For Smith & Nephew, these factors include:

economic and financial conditions in the markets we serve, especially those affecting health care providers, payers and customers; price levels for established and innovative medical devices; developments in medical technology; regulatory approvals, reimbursement decisions or other government actions; product defects or recalls or other problems with quality management systems or failure to comply with related regulations; litigation relating to patent or other claims; legal compliance risks and related investigative, remedial or enforcement actions; disruption to our supply chain or operations or those of our suppliers; competition for qualified personnel; strategic actions, including acquisitions and dispositions, our success in performing due diligence, valuing and integrating acquired businesses; disruption that may result from transactions or other changes we make in our business plans or organisation to adapt to market developments; and numerous other matters that affect us or our markets, including those of a political, economic, business, competitive or reputational nature. Please refer to the documents that Smith & Nephew has filed with the U.S. Securities and Exchange Commission under the U.S. Securities Exchange Act of 1934, as amended, including Smith & Nephew’s most recent annual report on Form 20-F, for a discussion of certain of these factors. Any forward-looking statement is based on information available to Smith & Nephew as of the date of the statement. All written or oral forward-looking statements attributable to Smith & Nephew are qualified by this caution. Smith & Nephew does not undertake any obligation to update or revise any forward-looking statement to reflect any change in circumstances or in Smith & Nephew’s expectations.

™Trademark of Smith & Nephew. Certain marks registered US Patent and Trademark Office.

Mayman DJ, Patel AR, Carroll KM. Hospital Related Clinical and Economic Outcomes of a Bicruciate Knee System in Total Knee Arthroplasty Patients.Poster presented at: ISPOR Symposium; May 19-23, 2018; Baltimore, Maryland, USA.
Nodzo, SR; Carroll KM, Mayman DJ. The Bicruciate Substituting Knee Design and Initial Experience. Tech Orthop. 2018;33:37-41.
Scott CE, Howie CR, MacDonald D, Biant LC; Predicting dissatisfaction following total knee replacement: a prospective study of 1217 patients. J Bone Joint Surg Br. 2010 Sep;92(9)
J Orthop. 2017 Jan 7;14(1):201-206. doi: 10.1016/j.jor.2016.12.005. eCollection 2017. Bi-cruciate substituting total knee arthroplasty improved medio-lateral instability in mid-flexion range
In Vivo Kinematic Comparison of a Bicruciate Stabilized Total Knee Arthroplasty and the Normal Knee Using Fluoroscopy Trevor F. Grieco, MS a, *, Adrija Sharma, PhD a, Garett M. Dessinger, BS a, Harold E. Cates, MD b, Richard D. Komistek, PhD. The Journal of Arthroplasty, September 2017
A comparison of Rolback Ratio between Bicruciate Substituting Total Knee Arthroplasty and Oxford Unicompartmental Knee Arthroplasty. DOI: 10.1055/s-0037-1604445. ISSN 1538-8506. The Journal of Knee Surgery. Takanori Iriuchishima, Keinosuke Ryu

SOURCE Smith & Nephew

Contacts

FBC Device ApS
Prof. FB Christensen
Email – finn@fbcdevice.com

July 23, 2018

BURLINGTON, Mass.–(BUSINESS WIRE)–Bone Biologics (OTCQB: BBLG), a developer of orthobiologic products for domestic and international spine fusion markets, announced today the completion of $5.9 million funding; $3.9 million in equity and a $2 million credit facility. Proceeds will be used for working capital, protein development, animal testing, regulatory and clinical expenses, as well as for other purposes not presently contemplated herein but which are related directly to growing the Company’s current business, research and development activities and the repayment of a secured promissory note in the principal amount of $600,000.

The securities offered have not been registered under the Securities Act of 1933, as amended, and may not be offered or sold in the United States absent registration or an applicable exemption from the registration requirements of the Securities Act and applicable state securities laws.

About Bone Biologics

Bone Biologics (OTCQB:BBLG) was founded to pursue regenerative medicine for bone.

Bone Biologics Corporation is undertaking groundbreaking work with select strategic partners, building on unprecedented research on the Nell-1 molecule that has produced a significant number of studies and publications in peer reviewed scientific literature.

Bone Biologics is currently focusing its development efforts for its bone graft substitute product on bone regeneration in spinal fusion and has rights to trauma and osteoporosis applications. Nell-1 is a recombinant human protein growth factor that is essential for normal bone development.

For more information, please visit the company’s website at www.bonebiologics.com.

Bone Biologics trades on the OTCQB venture stage marketplace for early stage and developing U.S. and international companies. OTCQB companies are current in their reporting and undergo an annual verification and management certification process. Investors can find Real-Time quotes and market information for the company on www.otcmarkets.com.

Forward-Looking Statements

This press release contains forward-looking statements that reflect the Company’s current beliefs, expectations or intentions regarding future events. Any statements contained in this press release that are not statements of historical fact may be deemed forward-looking statements. Words such as “will,” “will be,” “anticipate,” “predict,” “continue,” “future,” and similar expressions are intended to identify such forward-looking statements.

Disclaimer

This communication shall not constitute an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any sale of securities in any jurisdiction in which the offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction. No offering of securities shall be made except by means of a prospectus meeting the requirements of Section 10 of the Securities Act of 1933, as amended.

Contacts

Bone Biologics
Jeff Frelick, Chief Operating Officer
jfrelick@bonebiologics.com
or
Media Inquiries:
Tracy Williams, 310-824-9000
tracy@olmsteadwilliams.com

WALTHAM, Mass., July 23, 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, announced that Stephen Kennedy, Executive Vice President & Chief Operating Officer, has been appointed to the BioFabUSA Leadership Advisory Council and Technology Advisory Subcommittee (TASC) of the Advanced Regenerative Manufacturing Institute (ARMI).

ARMI is a new public-private Manufacturing USA initiative that brings together a consortium of nearly 100 organizations from industry, government, academia and the non-profit sector to develop next-generation manufacturing processes and technologies for cell and gene-based therapies.

“Innovation and the implementation of cutting-edge manufacturing process technologies has been a critical component of Histogenics’ development of NeoCart, and we know first-hand the importance of such technologies to realize the promise of restorative cell therapies,” said Mr. Kennedy. “I am pleased that ARMI has recognized Histogenics’ achievements in enabling this transformative therapeutic modality and grateful to have the opportunity to collaborate with other leaders in the cellular therapy field. The diverse backgrounds and perspectives of TASC’s members will help to ensure the development of manufacturing processes and technologies that support the clinical and commercial success of a broad array of cell therapies.”

Stephen Kennedy joined Histogenics in 2013 and has more than 30 years of experience in biological manufacturing and process development, including 18 years at Genzyme Corporation. He has also served as Executive Director of the Novartis/MIT Center for Continuous Manufacturing at the Massachusetts Institute of Technology. Stephen holds a B.S. from the University of Michigan, an M.S. from the University of Rochester and an M.B.A. from Boston University.

“We are delighted to have Steve Kennedy join the ARMI | BioFabUSA Leadership Advisory Council and Technology Advisory Subcommittee,” said inventor Dean Kamen, ARMI’s chairman. “His intelligence, experience and collaborative attitude are exactly what we need to bring engineers and scientists together to move this industry forward.”

About Advanced Regenerative Manufacturing Institute
The Advanced Regenerative Manufacturing Institute (ARMI), headquartered in Manchester, NH, is the 12^th Manufacturing USA Institute. It brings together a consortium of nearly 100 partners from across industry, government, academia and the non-profit sector to develop next-generation manufacturing processes and technologies for cells, tissues and organs. ARMI will work to organize the current fragmented domestic capabilities in tissue Biofabrication technology to better position the U.S. relative to global competition. For more information on ARMI, please visit www.ARMIUSA.org.

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 may prevent a patient’s progression to osteoarthritis. NeoCart is one of the most rigorously studied restorative cell therapies for orthopedic use. Histogenics completed enrollment of its NeoCart Phase 3 clinical trial in the second quarter of 2017 and expects to report top-line, one-year superiority data in the third quarter of 2018. 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, the timing and success of Histogenics’ NeoCart Phase 3 clinical trial 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 March 31, 2018, which are on file with the SEC and available on the SEC’s website at www.sec.gov. Additional factors may be set forth in those sections of Histogenics’ Quarterly Report on Form 10-Q for the quarter ended June 30, 2018, to be filed with the SEC in the third quarter of 2018. 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.

Contact:
Investor Relations
Tel: +1 (781) 547-7909
InvestorRelations@histogenics.com.

July 23, 2018

DURHAM, N.C.–(BUSINESS WIRE)–Bioventus, a global leader in orthobiologic solutions, has entered into a definitive agreement to divest its next generation bone morphogenetic protein (BMP) development program to a new company formed by Viscogliosi Brothers, LLC (VB), a private equity investment firm focused on developing innovative neuromusculoskeletal technologies.

Bioventus acquired the exclusive, worldwide license to the BMP portfolio of development programs and associated intellectual property from Pfizer, Inc., in 2013. The portfolio, which will now be sold to VB, includes the next-generation BMP in development, as well as a BMP program for soft tissue indications.

The transaction is expected to close in late Q3 and is conditional on VB having raised the requisite funds to complete the sale. When completed, Bioventus will receive an equity stake in the new company formed by Viscogliosi Brothers that will work on the BMP program. In addition, Bioventus will have an observational board seat to follow the progress being made as the work continues. The parties have agreed not to disclose the sale price.

“Divesting the BMP program gives us the opportunity to increase the R&D investment in other areas of our portfolio to support additional short and mid-term programs, while maintaining a stake in its development,” said Tony Bihl, CEO of Bioventus. “We now expect to leverage resources to make additional investments that will expand and grow our portfolio in osteoarthritis, surgical and non-surgical bone healing.”

“Stimulating the body to heal itself is the future of healthcare.” said Anthony G. Viscogliosi, Principal of Viscogliosi Brothers, LLC. “Viscogliosi Brothers has formed a new company to actualize this future by acquiring the next generation BMP development program of Bioventus. Through this acquisition, we are fortunate for Bioventus’ effort to enable us to take the next steps of initiating a clinical program to further evaluate the BMP technology to do safer, faster, and better healing for spine fusion.”

About Bioventus

Bioventus is an orthobiologics company that delivers clinically proven, cost-effective products that help people heal quickly and safely. Its mission is to make a difference by helping patients resume and enjoy active lives. The orthobiologic products from Bioventus include offerings for osteoarthritis, surgical and non-surgical bone healing. Built on a commitment to high quality standards, evidence-based medicine and strong ethical behavior, Bioventus is a trusted partner for physicians worldwide. For more information, visit www.BioventusGlobal.com and follow the company on Twitter @Bioventusglobal.

Bioventus and the Bioventus logo, are registered trademarks of Bioventus LLC

About Viscogliosi Brothers, LLC

Established by Marc R. Viscogliosi, John J. Viscogliosi and Anthony G. Viscogliosi in New York City, in 1999, Viscogliosi Brothers, LLC (VB), is a family office holding company specializing in venture capital, private equity and merchant banking in the neuro-musculoskeletal/orthopedic industry.

VB’s vision is dedicated to improving healthcare and the quality of life for humanity by finding innovative orthopedic concepts and supporting them to become sustainable technologies that can be commercialized globally to lead the evolution in orthopedic standards of care.

To accomplish this vision, VB discovers technologies, creates products and develops, builds, operates and finances companies founded on innovative and “life changing” technologies. VB principals have participated in more than 300 transactions, have invested in more than 20 companies and have formed more than ten funds.

Companies and funds that VB participated in have generated more than $1.5 billion in exit proceeds for investors through 14 exits in the last 18 years. Through its portfolio companies VB has defined 7 new orthopedic industry categories and its investments have helped commercialize more than 75 medtech devices, including eleven number one orthopedic technologies in seven market leading businesses.

VB orthopedic portfolio companies’ products have been implanted in nearly 300,000 people in more than 70 countries globally.

For additional information, please contact:

Anthony G. Viscogliosi, Principal
Email: aviscogliosi@vbllc.com
Website: www.vbllc.com

This press release shall not constitute an offer to sell or a solicitation of an offer to buy any securities. The securities have not been registered under the Securities Act of 1933 (the “Act”) and may not be offered or sold in the United States absent registration or an applicable exemption from registration requirements. This press release is being issued pursuant to and in accordance with Rule 135c under the Act.

Contacts

Bioventus
Thomas Hill, 919-474-6715
thomas.hill@bioventusglobal.com

by Hannah Rose Mendoza | Jul 13, 2018 | 3D Printing, Medical 3D Printing

While surgery has always, ultimately, been about the patient, it hasn’t always been patient-centered. Historically, patients have not had an easy time of understanding exactly what their surgery entails and have often been treated as if they were ancillary to the surgical problem presented. This can’t all be blamed on uncaring medical staff, as most people involved in medicine do care and care profoundly. Instead, it has largely been a result of resources and standing custom. Surgical procedures are complicated and difficult to understand, hence the reason why experts are the ones who address them, and the pressure and stress involved in going into a procedure largely blind has made it difficult for surgeons to relax and broaden their focus to include the patient beyond the problem.

3D technology is making great contributions to medicine, from aiding in research to assisting in the preparation of students to practice medicine to producing the tools necessary to perform better operations. It is being integrated into the surgical theater and changing the face of surgery as we know it. One of the ways it is doing this is through the provision of a greatly improved ability to plan for the procedure. 3D technology not only allows the medical team a sneak preview, 3D printing can create models of the particular areas to be addressed and allow surgeons to study them in advance. This helps minimize surprises and therefore reduces the stress on both the patient and the medical staff.

The staff at Orthoparc in the Netherlands has figured out another way to help create and deliver the best in patient centered care. Using 3D technology, they have developed a method of patient-centered total knee replacement that allows a patient to walk in, in the morning, and walk out that same day. Such a possibility requires a highly interconnected team of specialists working together to ensure that not only does the patient get the knee replacement they need, but their psychological, nutritional, and whole health needs are met as well.

One component of this is the integration of 3D printed, patient-specific surgical guides that take the uncertainty out of the procedure itself. These surgical guides are produced using data gathered about an individual patient’s knee and are fabricated in-house on a 3D printer. When placed upon the patient during surgery, they guide the surgeon to exactly where cuts need to be made in relationship to where the knee is resting. Dr. Saskia Boekhorst is an orthopedic surgeon at Orthoparc, and she described the impact these guides have had in her experience.

READ THE REST HERE

MISGAV, Israel, July 23, 2018 /PRNewswire/ —

OrthoSpin Ltd. (“OrthoSpin”), a portfolio company of The Trendlines Group Ltd. (“Trendlines”) (SGX: 42T) (OTCQX: TRNLY), announced that it completed an investment round of $3 million for its smart, robotic external fixation system for orthopedic treatments. Johnson & Johnson Innovation – JJDC, Inc. (“JJDC”) led the investment round.

External fixation devices are a common treatment choice for bone lengthening, setting complex fractures, and correcting deformities. Patient compliance challenges and a lack of real-time feedback for physician follow-up present substantial challenges. Currently, effective treatment necessitates that patients manually adjust fixation devices on a daily basis, requiring complicated patient training. This often causes adjustment errors and non-compliance results in poor clinical outcomes.

The OrthoSpin system makes pre-programmed adjustments automatically and continuously – without the need for patient involvement. Integrated software enables physicians to chart patient progress, and, when required, immediately adjust treatment programs. The accurate OrthoSpin system eliminates the need for weekly follow-up and is generally expected to improve patient experience resulting from smaller incremental adjustments with reduced soft tissue damage.

“We are delighted to have this investment and support from JJDC, as we continue the development of OrthoSpin,” said Oren Cohen, CEO of OrthoSpin. “The funding will enable us to accelerate our development process and broaden our clinical trials. We are confident that this investment will be an important step in bringing OrthoSpin’s system to market.”

About OrthoSpin

OrthoSpin was founded in December 2014, to offer a new robotic treatment system for use in orthopedics, specifically external fixation. OrthoSpin’s innovative system has the potential to change the outcomes of various orthopedic treatments, such as bone lengthening, setting complex fractures, and correcting deformities.

About Trendlines

Trendlines is an innovation commercialization company that invents, discovers, invests in, and incubates innovation-based medical and agricultural technologies to fulfil its mission to improve the human condition. As intensely hands-on investors, Trendlines is involved in all aspects of its portfolio companies from technology development to business building. Trendlines’ shares are traded on the Singapore Stock Exchange (SGX: 42T) and in the United States as an American Depositary Receipt (ADR) on the OTCQX International (OTCQX: TRNLY).

For further information:

Oren Cohen

CEO OrthoSpin

oren@orthospin.com

Phone +972-54-334-2651

SOURCE OrthoSpin Ltd. and The Trendlines Group Ltd.

July 23, 2018

MEQUON, Wis.–(BUSINESS WIRE)–Titan Spine, Inc., a medical device surface technology company focused on developing innovative spinal interbody fusion implants, today announced the appointment of Peter Wehrly to its Board of Directors. Mr. Wehrly’s appointment, effective July 9, 2018, provides the Company with extensive medtech market knowledge and experience as it continues to drive improved patient outcomes¹ through the deployment of its nanoLOCK^® surface technology.

nanoLOCK^® is the company’s next-generation surface technology featuring enhanced micro and nano-scaled architecture, proven to significantly improve the osteogenic response it creates.²

Mr. Wehrly commented, “Titan Spine has done a remarkable job forging the surface technology category in spine over the past several years and has the opportunity to continue its leadership position with the company’s unique nanoLOCK^® offering. I see a clear opportunity for the Company to further carve out a substantial share of the orthopedic market and look forward to contributing to Titan Spine’s growth and success.”

Mr. Wehrly is currently CEO of Synaptive Medical, a privately-held, Toronto-based company that combines proprietary surgical planning and robotic navigation platforms targeted initially for cranial and spinal applications. Prior to his appointment as CEO of Synaptive in October 2017, Mr. Wehrly was Chairman of the Board of Directors and an advisor to Synaptive from 2015 to 2017. From April 2016 to August 2017, Mr. Wehrly served as the CEO of PQ Bypass, a company based in Sunnyvale, California focused on breakthrough technology for the treatment of peripheral arterial disease. Previously, he was the Group President of Developed Markets at Covidien, a medical device manufacturer with annual sales of over $10.7 billion that was acquired by Medtronic, Inc. in 2015. In this position, Peter held profit and loss responsibility for the marketing and sale of products to all developed markets outside the U.S. between 2013 and 2015. Preceding this role, Peter was the Group President of Respiratory and Monitoring Solutions, Vascular Therapies, and for all of Covidien’s Japanese, Australian-New Zealand, and Canadian businesses. Prior to Covidien, Mr. Wehrly held the position of President and CEO at Medingo Youqneam, an Israel-based team that developed a novel insulin pump for diabetic patients. He also presided over Medtronic’s Spinal, Biologics, and Navigation businesses from 2004 to 2008. Peter started his career with DePuy, a Johnson & Johnson company.

Peter Ullrich, MD, Chief Executive Officer of Titan Spine, stated, “We recognize the importance of adding exceptional talent, guidance and expertise to our Board to help us continue driving Titan’s growth. Peter is a strategic leader who consistently delivers top-line growth and operational efficiencies across a wide range of global cultures. He has excelled in both public and private organizations, in both start-ups and multi-billion-dollar businesses, and in both developed and emerging markets. We are confident that Peter’s addition will advance our near and long-term goals for further building Titan Spine as the leader in surface technology medical devices.”

Titan Spine offers a full line of Endoskeleton^® titanium implants that feature its proprietary nanoLOCK^® surface technology, which was launched in October 2016 following FDA clearance in late 2014. The nanoLOCK^® surface technology consists of a unique combination of roughened topographies at the macro, micro, and nano levels (MMN™). This unique combination of surface topographies is designed to create an optimal host-bone response and actively participate in the fusion process by promoting the upregulation of osteogenic and angiogenic factors necessary for bone growth, encouraging natural production of bone morphogenetic proteins (BMPs), downregulating inflammatory factors, and creating the potential for a faster and more robust fusion.^2,3,4 All Endoskeleton^® devices are covered by the company’s risk share warranty.

About Titan Spine

Titan Spine, Inc. is a surface technology company focused on the design and manufacture of interbody fusion devices for the spine. The company is committed to advancing the science of surface engineering to enhance the treatment of various pathologies of the spine that require fusion. Titan Spine, headquartered in Mequon, Wisconsin, markets a full line of Endoskeleton^® interbody devices featuring its proprietary textured surface in the U.S., Europe, and Australia through its sales force and a network of independent distributors. To learn more, visit www.titanspine.com.

¹ Data on file.

² Olivares-Navarrete, R., Hyzy S.L., Gittens, R.A., Berg, M.E., Schneider, J.M., Hotchkiss, K., Schwartz, Z., Boyan, B. D. Osteoblast lineage cells can discriminate microscale topographic features on titanium-aluminum-vanadium surfaces. Ann Biomed Eng. 2014 Dec; 42 (12): 2551-61.

³Olivares-Navarrete, R., Hyzy, S.L., Slosar, P.J., Schneider, J.M., Schwartz, Z., and Boyan, B.D. (2015). Implant materials generate different peri-implant inflammatory factors: PEEK promotes fibrosis and micro-textured titanium promotes osteogenic factors. Spine, Volume 40, Issue 6, 399–404.

⁴Matteson JL, Greenspan DC, Tighe TB, et al. Assessing the hierarchical structure of titanium implant surfaces. Journal of Biomedical Materials Research Part B Applied Biomaterials 104(6). May 2015. DOI:10.1002/jbm.b.33462.

Contacts

Titan Spine
Andrew Shepherd, 866-822-7800
ashepherd@titanspine.com
or
Media
The Ruth Group
Kirsten Thomas, 508-280-6592
kthomas@theruthgroup.com

HOLLAND, Mich., July 19, 2018 /PRNewswire/ — Genesis Innovation Group, LLC, announces the formation of HAPPE Spine LLC as well as investments by cultivate(MD) Capital Fund I, LLC and cultivate(MD) Capital Fund II, LP into HAPPE Spine.

Based on the work of Ryan K. Roeder, Ph.D. and researchers from the University of Notre Dame, HAPPE Spine has developed and will commercialize a material technology that allows for the construction of partial or fully porous hydroxyapatite reinforced polyetheretherketone (PEEK) implants.

Hydroxyapatite (HA) has been shown to encourage osteointegration of implants due to the unique nature of this material providing a very bone-friendly surface. HA whisker reinforced PEEK with variable porosity allows HAPPE to create advanced spinal interbody implants.

Dr. Roeder explained, “More than a decade ago, we envisioned that modifying PEEK to be both porous and bioactive would provide an ideal implant material solution for interbody spinal fusion. At that time, the market was not yet prepared for this innovation. As surgeons are now recognizing the advantages of utilizing bioactive hydroxyapatite enhanced PEEK or surface-porous PEEK, we are excited to combine both innovations into the same device.”

Dave Blue, Managing Director of cultivate(MD) said, “We believe the technology has the potential to provide significant differentiation in the spinal interbody market. But there are numerous other potential applications throughout the body and HAPPE will evaluate additional device applications as part of the product strategy.”

Rob Ball, Chairman and CEO, Genesis Innovation Group said, “Genesis is excited to have the opportunity to partner with Dr. Roeder and engage this exciting technology. The experienced talent at Genesis Innovation Group combined with financial capital at cultivate(MD) make for a powerful combination when envisioning the future of these types of innovations. Many orthopedic indications would benefit from a strong, bioactive, osteointegrative, and radiolucent material. We are making fast progress and continuing the development of this technology and products.”

Genesis Innovation Group and cultivate(MD) Capital Funds look forward to partnering with the developers of the material technology, all who will continue to be engaged with the Company as owners, investors, and advisors.

About cultivate(MD) Capital Funds

As a medical device venture capital fund, cultivate(MD) is dedicated to bringing emerging health care innovations to market, with a special focus on medical device and orthopedic technologies. cultivate(MD) is focused on investing in early stage healthcare companies with innovative technologies that have demonstrated evidence of effectiveness.

This press release does not constitute an offer to sell or solicitation of an offer to buy any securities in any offering of securities. There will not be any sale of any securities in any state or jurisdiction in which such offering, sale or solicitation would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

Contact:

Matt Ahearn

Vice President of Finance and Operations

https://genesisinnovationgroup.com/contact-us/

Forwarding-Looking Statements

Certain Statements in this press release constitute forward-looking statements. When used in this press release, the words “will,” “anticipate,” and similar expressions or the negatives thereof are generally intended to identify forward-looking statements. Such forward-looking statements, including the intended actions and performance objectives of fund, its general partner, cultivate(MD) or any cultivate(MD) portfolio company referenced herein, involve known and unknown risks, uncertainties, and other important factors that could cause the actual results, performance, or achievements of the general partner, or any cultivate(MD) fund or portfolio company to differ materially from any future results, performance, or achievements expressed or implied by such forward-looking statements. No representation or warranty is made as to future performance or such forward-looking statements. All forward-looking statements in this press release speak only as of the date hereof. The fund, its general partner and cultivate(MD) expressly disclaim any obligation or undertaking to disseminate any updates or revisions to any forward-looking statement contained herein to reflect any change in its expectation with regard thereto or any change in events, conditions, or circumstances on which any such statement is based.

SOURCE cultivate(MD)

WASHINGTON, July 19, 2018 /PRNewswire/ — Musculoskeletal Clinical Regulatory Advisers, LLC (MCRA), a leading advisory firm and Clinical Research Organization (CRO) to the medical device industry, is pleased to announce the recent hire of Bonnie Clothier, PhD, RN, as its Associate Director, Payor Relations, to further expand its medical technology reimbursement payor relations expertise and service offerings.

Ms. Clothier most recently worked for Independence Blue Cross where she was responsible for reviewing and updating medical policy coverage positions, providing clinical rationale for appropriateness of medical billing codes (ICD10, CPT and HCPCS), and analyzing utilization patterns of claims data.

In her role at MCRA, Ms. Clothier will be responsible for providing internal and customer support to help identify specific payor issues and develop plans for gaining or improving U.S. coverage with health plans for new and innovative technologies.

Ms. Clothier said, “I am honored to join a talented, dynamic firm where I can leverage my private payor experience with my clinical and research background to assist MCRA’s clients with successfully obtaining covered access to evidenced-based care.”

Tim Hunter, MCRA’s Vice President of Health Economics, Reimbursement, and Public Policy said, “MCRA has a long history of working with payors to help them understand the important role and benefits of innovative medical devices and their associated procedures. We are excited that Bonnie has joined our Payor Relations team; with her combination of clinical and commercial insurance experience she will expand our ability to provide patient access to appropriate medical care.”

For more information on MCRA, please visit www.mcra.com

About MCRA

Founded in 2004, Musculoskeletal Clinical Regulatory Advisers, LLC (MCRA) is a leading adviser and clinical research organization to the neuro-musculoskeletal and orthopedic industry. MCRA’s value lies in its industry experience and integration of five business value creators: regulatory, reimbursement, clinical research, healthcare compliance and quality assurance. MCRA’s integrated approach of these key value creating initiatives provides unparalleled expertise for its clients. MCRA has offices in Washington, DC, Manchester, CT and New York, NY, and serves nearly 500 clients globally. MCRA has a demonstrated history of driving success in all areas of the medical device industry including spine, orthopedics, cardio-vascular, diagnostic imaging, endoscopy, ophthalmics, general/plastic surgery, drug delivery, wound care, diabetes, dental, general healthcare, nephrology, neurology, cardiology, and in vitro diagnostic (IVD) devices.

Contact

David W. Lown

General Manager, MCRA, LLC

Phone: 212.583.0250 ext. 2111

Email: dlown@mcra.com

SOURCE Musculoskeletal Clinical Regulatory Advisers, LLC

Search

3 days / 6 sessions
Current Issues in Spine

JOURNEY™ II BCS Knee System demonstrates improved patient outcomes and lower healthcare costs

Related Links

FBC Device ApS Receives First FDA Clearance For Spinal Interbody Implant Providing Lordosis Adjustment from 9 to 21 Degrees to Aid Surgeons & Patients

Contacts

Bone Biologics Completes $5.9 Million of Financing

Contacts

Histogenics Chief Operating Officer, Stephen Kennedy Appointed to Advanced Regenerative Manufacturing Institute’s Technology Advisory Sub-Committee

Bioventus Enters Into Definitive Agreement to Divest BMP Development Program to Viscogliosi Brothers, LLC

Contacts

Using Patient-Specific 3D Printed Surgical Guides for Total Knee Replacement

OrthoSpin Ltd. Completes $3 Million Raise for Orthopedic Robotic External Fixation System

Titan Spine Appoints Peter Wehrly to Board of Directors

Contacts

cultivate(MD) Funds Announce Investments Into Happe Spine

MCRA Hires Bonnie Clothier, PhD, RN, Associate Director, Payor Relations, to Further Expand Reimbursement Payor Relations Service Division

Related Links

STAR Ankle Joint Replacements Last Long Term and Provide Relief for Patients

Medacta USA’s Spine Division Begins 2017 with Key Appointment, Significant Growth

Spinal Stabilization Technologies Announces Start of LOPAIN 2 Clinical Trial in South America for Lumbar Degenerative Disc Disease

$250K Pediatric Device Competition Now Accepting Proposals

First Single-Use Rigid Endoscope to be Demonstrated at AAOS