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Extremities

Anika Announces Publication of Phase III Data Demonstrating the Efficacy and Safety of CINGAL®

May 23, 2017 OrthoSpineNews

BEDFORD, Mass.–(BUSINESS WIRE)–Anika Therapeutics, Inc. (NASDAQ: ANIK), a global, integrated orthopedics medicines company specializing in therapeutics based on its proprietary hyaluronic acid (“HA”) technology, today announced the publication of Phase III data demonstrating the efficacy and safety of CINGAL®, its novel HA-corticosteroid combination viscosupplement for the treatment of symptoms associated with osteoarthritis (“OA”) of the knee. The data, published in this month’s issue of the peer-reviewed journal Cartilage, demonstrated that CINGAL provided superior immediate and short term pain relief after injection as compared to HA alone, and superior relief from OA-related pain, stiffness and function through 26 weeks as compared to saline. These Phase III study results were part of the comprehensive clinical data package that formed the basis for CINGAL’s CE Mark and Health Canada approval in 2016.

“We are excited to share published, peer-reviewed Phase III data that validates the efficacy, safety and clinical significance of our novel viscosupplement, CINGAL,” said Charles H. Sherwood, Ph.D., President and Chief Executive Officer of Anika Therapeutics. “CINGAL fulfills a tremendous unmet clinical need for a low-volume corticosteroid and hyaluronic acid combination viscosupplement that has an established track record of safety and efficacy, and provides immediate and long-term relief from knee OA symptoms for 6 months and potentially beyond.”

CINGAL is the first and only viscosupplement that combines triamcinolone hexacetonide, a well-established, FDA-approved steroid that may be utilized to treat inflammation, with Anika’s proprietary cross-linked, non-animal-derived hyaluronic acid, which is the active “cushioning” ingredient in the global market-leading viscosupplements, ORTHOVISC® and MONOVISC®. Viscosupplements are injected by a licensed medical professional into synovial joints to replenish the natural cushioning within joints that depletes with age and degenerative orthopedic diseases, causing pain.

The multicenter, double-blind, saline-controlled clinical trial evaluated 368 patients with knee osteoarthritis who were randomized for treatment with a single injection of CINGAL (n=149), MONOVISC (n=150) or saline (n=69). Changes in pain, stiffness and physical function were assessed using a variety of validated measurement tools including the Western Ontario and McMaster Universities Arthritis Index (WOMAC)1.

Below are the key findings:

  • CINGAL reduced WOMAC Pain by 70% at 12 weeks and 72% at 26 weeks as compared to saline – more improvement than that reported in previous viscosupplement studies.2, 3, 4, 5
  • CINGAL demonstrated rapid pain relief following administration (a 59% improvement in WOMAC Pain at 1 week and 68% at 3 weeks) – unmatched by prior trials of triamcinolone hexacetonide alone.6, 7
  • CINGAL met all primary and secondary endpoints relative to saline in the ITT analysis.
  • CINGAL demonstrated significant improvement with respect to most secondary endpoints for pain and function at most time points through 26 weeks.
  • At 1 and 3 weeks, CINGAL was significantly better than MONOVISC for most endpoints.
  • CINGAL and MONOVISC provided similar benefits from 6 weeks through 26 weeks.
  • CINGAL was shown to be safe, and was associated with a low incidence of adverse events (n=6) that resolved over time. There were no serious adverse events considered to be related to CINGAL.

“Steroid injections and hyaluronic acid-based viscosupplements are two forms of effective non-surgical interventions to manage knee osteoarthritis,” said Prof. Laszlo Hangody, MD, Ph.D., DSc., the study’s lead author, Clinical Professor at the Debrecen Medical School and Senior Consultant in the Orthopaedic Department at Uzsoki Hospital, Budapest, Hungary. “By combining a proven viscosupplement, MONOVISC, with an established steroid in a single injection, CINGAL gives patients a safe, convenient and highly effective treatment option for immediate and sustained relief from the debilitating symptoms of knee OA.”

CINGAL is commercially available in certain countries of the European Union (E.U.), and Canada, and is under regulatory review in the United States. Anika recently completed site initiation in the E.U. to begin enrolling patients in a supplemental Phase III study requested by the U.S. Food and Drug Administration. Anika anticipates FDA approval of CINGAL after it completes the study in 2018.

About Anika Therapeutics, Inc.

Anika Therapeutics, Inc. (NASDAQ: ANIK) is a global, integrated orthopedic medicines company based in Bedford, Massachusetts. Anika is committed to improving the lives of patients with degenerative orthopedic diseases and traumatic conditions with clinically meaningful therapies along the continuum of care, from palliative pain management to regenerative cartilage repair. The Company has over two decades of global expertise developing, manufacturing, and commercializing more than 20 products based on its proprietary hyaluronic acid (HA) technology. Anika’s orthopedic medicine portfolio includes ORTHOVISC, MONOVISC, and CINGAL, which alleviate pain and restore joint function by replenishing depleted HA, and HYALOFAST®, a solid HA-based scaffold to aid cartilage repair and regeneration. For more information about Anika, please visit www.anikatherapeutics.com.

Forward-Looking Statements

The statements made in the third sentence of the final paragraph of this press release, which are not statements of historical fact, are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These statements include, but are not limited to, those relating to the Company’s expectations regarding the Company’s supplemental Phase III study for CINGAL and FDA approval of CINGAL. These statements are based upon the current beliefs and expectations of the Company’s management and are subject to significant risks, uncertainties, and other factors. The Company’s actual results could differ materially from any anticipated future results, performance, or achievements described in the forward-looking statements as a result of a number of factors including, but not limited to, (i) the Company’s ability to successfully commence and/or complete clinical trials of its products on a timely basis or at all; (ii) the Company’s ability to obtain pre-clinical or clinical data to support domestic and international pre-market approval applications, 510(k) applications, or new drug applications, or to timely file and receive FDA or other regulatory approvals or clearances of its products; (iii) that such approvals will not be obtained in a timely manner or without the need for additional clinical trials, other testing or regulatory submissions, as applicable; (iv) the Company’s research and product development efforts and their relative success, including whether we have any meaningful sales of any new products resulting from such efforts; (v) the cost effectiveness and efficiency of the Company’s clinical studies, manufacturing operations, and production planning; (vi) the strength of the economies in which the Company operates or will be operating, as well as the political stability of any of those geographic areas; (vii) future determinations by the Company to allocate resources to products and in directions not presently contemplated; (viii) the Company’s ability to successfully commercialize its products, in the U.S. and abroad; (ix) the Company’s ability to provide an adequate and timely supply of its products to its customers; and (x) the Company’s ability to achieve its growth targets. Additional factors and risks are described in the Company’s periodic reports filed with the Securities and Exchange Commission, and they are available on the SEC’s website at www.sec.gov. Forward-looking statements are made based on information available to the Company on the date of this press release, and the Company assumes no obligation to update the information contained in this press release.

1 Western Ontario and McMaster Universities Arthritis Index (WOMAC) is a widely used, proprietary set of standardized questionnaires used by health professionals to evaluate the condition of patients with osteoarthritis of the knee and hip, including pain, stiffness and physical functioning of the joints.
2 Chevalier X, Jerosch J, Goupille P, van DN, Luyten FP, Scott DL, et al. Single, intra-articular treatment with 6 ml hylan G-F 20 in patients with symptomatic primary osteoarthritis of the knee: a randomised, multicentre, double-blind, placebo controlled trial. Ann Rheum Dis 2010;69:113-119
3 Strand V, Baraf HS, Lavin PT, Lim S, Hosokawa H. A multicenter, randomized controlled trial comparing a single intra-articular injection of Gel-200, a new cross-linked formulation of hyaluronic acid, to phosphate buffered saline for treatment of osteoarthritis of the knee. Osteoarthritis Cartilage 2012;20:350-356
4 Karlsson J, Sjogren LS, Lohmander LS. Comparison of two hyaluronan drugs and placebo in patients with knee osteoarthritis. A controlled, randomized, double-blind, parallel-design multicentre study. Rheumatology 2002;41:1240-1248
5 Neustadt D, Caldwell J, Bell M, Wade J, Gimbel J. Clinical effects of intraarticular injection of high molecular weight hyaluronan (Orthovisc) in osteoarthritis of the knee: a randomized, controlled, multicenter trial. J Rheumatol 2005;32:1928-1936
6 Pyne D, Ioannou Y, Mootoo R, Bhanji A. Intra-articular steroids in knee osteoarthritis: a comparative study of triamcinolone hexacetonide and methylprednisolone acetate. Clin Rheumatol 2004;23:116-120
7 Frias G, Caracuel MA, Escudero A, Rumbao J, Perez-Gujo V, del Carmen CM, et al. Assessment of the efficacy of joint lavage versus joint lavage plus corticoids in patients with osteoarthritis of the knee. Curr Med Res Opin 2004;20:861-867

Contacts

For Investor Inquiries:
Anika Therapeutics, Inc.
Sylvia Cheung, 781-457-9000
Chief Financial Officer
or
For Media Inquiries:
Pure Communications
Susan Heins, 864-286-9597

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Biologics

Anika Celebrates 25th Anniversary and Inaugurates Newly Expanded Global Manufacturing Facility

May 23, 2017 OrthoSpineNews

BEDFORD, Mass.–(BUSINESS WIRE)–Anika Therapeutics, Inc. (NASDAQ: ANIK), a global, integrated orthopedics medicines company specializing in therapeutics based on its proprietary hyaluronic acid (“HA”) technology, is hosting a celebration today at its Bedford, Massachusetts headquarters to commemorate its 25th anniversary and inaugurate its newly-expanded and consolidated global manufacturing facility. Previously, Anika’s manufacturing operations were split between its U.S. headquarters and a contract manufacturer in Abano Terme, Italy, but the company initiated plans to onshore manufacturing in the U.S. to maintain better control of supply chain, accelerate product development, and increase operating efficiency. By year end, our 134,000 square foot corporate headquarters and the newly expanded state-of-the-art facility will manufacture and package the totality of the company’s diverse portfolio of more than 20 products for distribution into more than 55 markets across the globe.

“We are proud and excited to consolidate our entire manufacturing operation in the United States on the 25th anniversary of our inception,” said Charles H. Sherwood, Ph.D., President and Chief Executive Officer, Anika Therapeutics. “The new facility not only helps Anika more deftly manage global supply and inventory, but it also creates opportunities for a highly-skilled workforce, and brings sophisticated scientific capabilities and cutting-edge technologies back to the U.S. and to the state of Massachusetts, which has been a steadfast and supportive partner throughout our 25-year journey.”

Anika develops, manufactures and commercializes a diverse range of therapeutic products, the large majority of which are based on its proprietary formulation of non-animal-derived HA, a naturally occurring substance in the human body with lubricating, healing, restorative and regenerative properties. In the Bedford-based manufacturing facility, Anika utilizes proprietary processes to produce its suite of unique gel-based and textile-form products from highly-concentrated and ultra-pure HA. Anika’s Bedford-based manufacturing facility and corporate headquarters employs approximately 100 operations, engineering, clinical, assembly, warehouse, marketing, general and administrative professionals, and it is the only facility in the U.S. with the sophisticated capability to produce HA products in solid textile forms.

“We welcome Anika Therapeutics’ decision to bring its healthcare manufacturing sector back to the U.S. and to the Commonwealth as they celebrate 25 years supporting our local economy,” said Governor Charlie Baker. “Our strong and talented workforce is helping businesses large and small thrive, supporting economic growth and new jobs across Massachusetts.”

“For 25 years Anika Therapeutics has provided value and stability to not just the life sciences industry, but the Commonwealth as a whole. With this upcoming expansion, the anticipated and sustained impact on the local and state economy cannot be overstated,” Travis McCready, President & CEO of the Massachusetts Life Sciences Center said. “On behalf of the Massachusetts Life Sciences Center, I congratulate Anika on these first 25 years, and look forward to their continued success for the next quarter century and beyond, here in Massachusetts.”

“Congratulations to Anika and its leadership on celebrating 25 years of success and growth,” said Robert K. Coughlin, CEO and President of MassBio. “Their longevity and commitment to innovation is a shining example for other Massachusetts companies who are looking to follow their lead.”

About Anika Therapeutics, Inc.

Anika Therapeutics, Inc. (NASDAQ: ANIK) is a global, integrated orthopedic medicines company based in Bedford, Massachusetts. Anika is committed to improving the lives of patients with degenerative orthopedic diseases and traumatic conditions with clinically meaningful therapies along the continuum of care, from palliative pain management to regenerative cartilage repair. The Company has over two decades of global expertise developing, manufacturing, and commercializing more than 20 products based on its proprietary hyaluronic acid (HA) technology. Anika’s orthopedic medicine portfolio includes ORTHOVISC®, MONOVISC®, and CINGAL®, which alleviate pain and restore joint function by replenishing depleted HA, and HYALOFAST®, a solid HA-based scaffold to aid cartilage repair and regeneration. For more information about Anika, please visit www.anikatherapeutics.com.

Forward-Looking Statements

The statements made in the last sentence of the first paragraph of this press release, which are not statements of historical fact, are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These statements include, but are not limited to, those relating to the Company’s expectations regarding 2017 production capabilities. These statements are based upon the current beliefs and expectations of the Company’s management and are subject to significant risks, uncertainties, and other factors. The Company’s actual results could differ materially from any anticipated future results, performance, or achievements described in the forward-looking statements as a result of a number of factors including, but not limited to, (i) the Company’s ability to successfully commence and/or complete clinical trials of its products on a timely basis or at all; (ii) the Company’s ability to obtain pre-clinical or clinical data to support domestic and international pre-market approval applications, 510(k) applications, or new drug applications, or to timely file and receive FDA or other regulatory approvals or clearances of its products; (iii) that such approvals will not be obtained in a timely manner or without the need for additional clinical trials, other testing or regulatory submissions, as applicable; (iv) the Company’s research and product development efforts and their relative success, including whether we have any meaningful sales of any new products resulting from such efforts; (v) the cost effectiveness and efficiency of the Company’s clinical studies, manufacturing operations, and production planning; (vi) the strength of the economies in which the Company operates or will be operating, as well as the political stability of any of those geographic areas; (vii) future determinations by the Company to allocate resources to products and in directions not presently contemplated; (viii) the Company’s ability to successfully commercialize its products, in the U.S. and abroad; (ix) the Company’s ability to provide an adequate and timely supply of its products to its customers; and (x) the Company’s ability to achieve its growth targets. Additional factors and risks are described in the Company’s periodic reports filed with the Securities and Exchange Commission, and they are available on the SEC’s website at www.sec.gov. Forward-looking statements are made based on information available to the Company on the date of this press release, and the Company assumes no obligation to update the information contained in this press release.

Contacts

For Investor Inquiries:
Anika Therapeutics, Inc.
Sylvia Cheung, 781-457-9000
Chief Financial Officer
or
For Media Inquiries:
Pure Communications
Susan Heins, 864-286-9597

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Sports Medicine

OrthoMemphis Performs First Meniscus Replacement in Tennessee with NUsurface® Implant

May 23, 2017 OrthoSpineNews

MEMPHIS, Tenn.–(BUSINESS WIRE)–OrthoMemphis and Active Implants, a Memphis-based company that develops orthopedic implant solutions, today announced that the first meniscus replacement procedure in Tennessee was successfully performed.

Dr. Randall Holcomb, sports medicine orthopaedic surgeon and president of OrthoMemphis, was the surgeon selected for the study due to his 30 years of expertise in area of cartilage restoration and transplantation. OrthoMemphis is the only center in Tennessee – and just one of 10 sites nationwide – participating in the VENUS (Verification of the Effectiveness of the NUsurface® System) clinical trial, which is enrolling patients with persistent knee pain after loss of meniscus cartilage to assess the safety and effectiveness of the investigational NUsurface Meniscus Implant compared to non-surgical standard of care.

The meniscus is a tissue pad between the thigh and shin bones. Once it is damaged, the meniscus has a very limited ability to heal, and therefore meniscus surgery is performed to remove the torn painful portion of the meniscus. Over 1 million partial meniscectomies are performed in the U.S. every year, more than the total number of hip and knee replacement surgeries combined. While partial meniscectomy surgery is tremendously successful, there is still a subset of patients that continue to experience pain following meniscal surgery. These patients tend to have deteriorating meniscus cartilage, which remains painful and can evolve into arthritis requiring a total knee replacement.

The first patient to receive the NUsurface Meniscus Implant in Tennessee is Memphis resident Dr. Tim Goldsmith. He suffered a knee injury two years ago while practicing twisting lunges during a workout session. This injury led the 60-year-old to undergo alternative treatments to treat the pain, including muscle strengthening physical therapy, injections to relieve pain and finally a partial meniscectomy on his left knee. However, he continued to have consistent knee pain on a daily basis that impacted any activity – from playing golf and interval workout training classes to simply walking up and down stairs.

“There are few options for patients who experience persistent knee pain following meniscus surgery,” Dr. Holcomb said. “We hope the NUsurface implant will act as an artificial meniscus to alleviate their pain and hopefully prevent the onset of degenerative joint disease. Although at this time we cannot make the claim, the NUsurface device may be the solution to slowing down or preventing degenerative arthritis associated with meniscal injuries.”

Dr. Holcomb implanted the device in April 2016 through a small incision in Goldsmith’s knee. Goldsmith was able to quickly return to his work as chief clinical officer at Youth Villages, a private nonprofit dedicated to helping thousands of emotionally and behaviorally troubled children and their families live successfully. Following the full six-week physical therapy regimen with OrthoMemphis’ Steven Chipman,Goldsmith also resumed his favorite pastimes, including golf, spin classes, and interval strength and resistance training. Since his surgery, Goldsmith’s knee has been stable and he has continued his active lifestyle.

“Prior to receiving the NUsurface Meniscus Implant, I felt like I was out of options and had resigned myself to living with pain and waiting for eventual knee replacement,” Goldsmith said. “Now, I am not only rid of the knee pain, but am also experiencing better mobility and flexibility – this gives me hope that I will have the ability to stay as active as I’d like to be for as long as I can.”

The NUsurface Meniscus Implant is inserted into the knee joint through a small incision, and patients typically can go home on the same day of the operation. After surgery, they undergo a six-week rehabilitation program. NUsurface has been used in Europe since 2008 and Israel since 2011.

About the Clinical Trial

As part of the process to gain regulatory approval in the U.S., the VENUS (Verification of the Effectiveness of the NUsurface® System) study will enroll approximately 130 patients at orthopedic centers in the U.S., Europe and Israel. Sites in the U.S. include Indiana (Indianapolis), Massachusetts (Boston), New York (Albany, Rochester and New York), North Carolina (Durham), Ohio (Columbus), Tennessee (Memphis) and Virginia (Richmond). Participants who meet study requirements and agree to enter the trial are randomized to receive either the NUsurface device or non-surgical treatment, which is the current standard of care for patients with persistent knee pain following meniscus surgery. To be eligible for the study, participants must be between the ages of 30 and 75 and have pain after medial meniscus surgery that was performed at least six months ago. To learn more about the VENUS study, please call (844) 680-8951 or visit www.meniscus-trial.com.

About the NUsurface® Meniscus Implant

In the U.S., the NUsurface® Meniscus Implant, from Active Implants LLC, is an investigational treatment for patients with persistent knee pain following medial meniscus surgery. The NUsurface Meniscus Implant is made from medical grade plastic and, as a result of its unique materials, composite structure and design, does not require fixation to bone or soft tissue. The NUsurface device mimics the function of the natural meniscus and redistributes loads transmitted across the knee joint. It is inserted into the knee joint through a small incision, and patients typically can go home soon after the operation. After surgery, patients undergo a six-week rehabilitation program. The NUsurface device has been used clinically in Europe since 2008 and Israel since 2011.

About OrthoMemphis

OrthoMemphis’ team of 18 doctors provides surgical and non-surgical treatment in general orthopedic and subspecialty areas of sports medicine, spine, hand, foot & ankle, hip & knee, total joint replacement, treatments of bone and soft tumors of the extremities (benign and malignant) in children and adults, and workers’ compensation injuries. Fellowship trained surgeons provide expert care in each subspecialty. For more information, go to http://www.orthomemphis.com/.

About Active Implants

Active Implants, LLC develops orthopedic implant solutions that complement the natural biomechanics of the musculoskeletal system, allowing patients to maintain or return to an active lifestyle. Active Implants is privately held with headquarters in Memphis, Tennessee. European offices are in The Netherlands, with R&D facilities in Israel. For more information, visit www.activeimplants.com.

CAUTION Investigational device. Limited by United States law to investigational use.

Contacts

Merryman Communications
Joni Ramirez, 323-532-0746
joni@merrymancommunications.com

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BiologicsTop Stories

CollPlant Signs New Exclusive Distribution Agreement in Turkey for Vergenix®FG Wound Treatment

May 23, 2017 OrthoSpineNews

NES ZIONA, Israel, May 22, 2017 /PRNewswire/ — CollPlant (TASE: CLPT), a regenerative medicine company utilizing its proprietary plant-based rhCollagen (recombinant human “rhCollagen”) technology for tissue repair products announced that the Company has signed a new, exclusive distributor agreement in Turkey to market Vergenix®FG, for the treatment of chronic wounds. The one year agreement includes a two-year extension option. The market potential for the treatment of chronic wounds in Turkey is estimated at in excess of 400,000 procedures annually.

Yehiel Tal, Chief Executive Officer of CollPlant, noted, “We have received excellent feedback from opinion leaders in Europe who have been using the product, and the signing of the agreement with the Turkish distributor represents a further layer in the implementation of the Company’s sales strategy on the continent. Our objective is to build up the sales infrastructure for Vergenix®FG through distributors in various, key territories.”

Below is a link to a video review by Professor Alberto Piaggesi, M.D., Director of the Diabetic Foot Section of the Pisa University Hospital, Italy and a member of the Council of the European Wound Management Association (EWMA). Dr. Piaggesi, who uses Vergenix®FG to treat patients with hard to heal chronic wounds, describes the product’s advantages and its success in closing wounds. (Warning: the video includes pictures from treatment that some viewers might find distressing).

CollPlant Vergenix FG – Prop. Alberto Piaggesi – Youtube

About Vergenix®FG

Vergenix®FG is an injectable gel compound based on the Company’s human collagen, which has shown to treat chronic wounds and operation-based incisions, including diabetic foot ulcer. The gel is injected directly into the wound, thereby filling it and facilitating a healing process through to complete wound closure, without any side effects such as infections or allergies which may occur with other treatment options.

About CollPlant

CollPlant is a regenerative medicine company leveraging its proprietary, plant-based recombinant human collagen (rhCollagen) technology for the development and commercialization of tissue repair products, initially for the orthobiologics, 3D Bio-printing of tissue and organs, and advanced wound care markets. The Company’s cutting-edge technology is designed to generate and process proprietary rhCollagen, among other patent-protected recombinant proteins. Given that CollPlant’s rhCollagen is identical to the type I collagen produced by the human body, it offers significant advantages compared to currently marketed tissue-derived collagen, including improved biofunctionality, superior homogeneity and reduced risk of immune response. The Company’s broad development pipeline includes biomaterials indicated for orthopedics and advanced wound healing. Lead products include: Vergenix®STR (Soft Tissue Repair Matrix), for the treatment of tendinopathy; and Vergenix®FG (Flowable Gel) wound filler, for treatment of acute and chronic wounds. CollPlant’s business strategy includes proprietary development and manufacture of tissue repair products and their commercialization and distribution, together with leading third parties, alongside alliances with leading companies for joint development, manufacture and marketing of additional products.

For more information about CollPlant, visit http://www.collplant.com

Contact at CollPlant:                                   

Eran Rotem
Chief Financial Officer
Tel: + 972-73-2325600/612
Email: Eran@collplant.com

Contact at Rx Communications Group, LLC:

Paula Schwartz (for US Investors)
Managing Director
Tel: 917-322-2216
Email: pschwartz@rxir.com

SOURCE CollPlant

Related Links

http://www.collplant.com

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BiologicsFinancialTop Stories

Organogenesis Closes on a $20 Million Facility from Eastward Capital Partners

May 23, 2017 OrthoSpineNews

CANTON, Mass., May 22, 2017 /PRNewswire/ — Organogenesis Inc., a commercial leader in the field of regenerative medicine focusing on advanced wound care and surgical biologics, today closed a $20 million financing facility with Eastward Capital Partners, a leading provider of venture debt and equity financing to technology companies.

“We were fortunate to have several choices in a financing partner as we continue to build our balance sheet and our product portfolio to provide the most advanced wound care and surgical biologics solutions to our customers,” said Tim Cunningham, Chief Financial Officer of Organogenesis Inc. “We chose Eastward Capital Partners given their impeccable credentials and stellar reputation, which aligns well with Organogenesis’ core values.  Additionally, Eastward Capital Partners has decades of experience financing health technology companies and understands the value our products bring to clinicians and patients.”

“Eastward Capital Partners is committed to partnering with technology-forward companies who are leaders in their industry segments,” said Eastward Partner’s Tim O’Loughlin. “We are excited to partner with Organogenesis to provide the capital to support their growth plans.”

About Organogenesis Inc.
Originally founded as a spin-off from technology developed at MIT in 1985, Massachusetts-based Organogenesis Inc. is a global leader in regenerative medicine, offering a portfolio of bioactive and acellular biomaterials products for advanced wound care, orthopedics, and spine. Organogenesis’ versatile portfolio is designed to treat a variety of patients with repair and regenerative needs. For more information, visit www.organogenesis.com.

About Eastward Capital Partners
Eastward has provided private debt to leading companies in the Information Technology, Communications, New Media and Healthcare sectors since 1994.  As one of the oldest and most respected investors in the market, Eastward has a long history of working with companies to craft funding solutions which allow companies to reach their full potential.  www.eastwardcp.com

CONTACT:
Angelyn Lowe
(781) 830-2353
alowe@organo.com

SOURCE Organogenesis Inc.

Related Links

http://organogenesis.com/

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Spine

NuVasive Announces Educational Initiatives In Support Of Spine’s Fastest Growing Spinal Deformity Portfolio

May 23, 2017 OrthoSpineNews

SAN DIEGO, May 22, 2017 /PRNewswire/ — NuVasive, Inc. (NASDAQ: NUVA), a leading medical device company focused on transforming spine surgery with minimally disruptive, procedurally-integrated solutions, today announced the Company’s increased investment and support of adult and pediatric deformity research, education, and awareness initiatives throughout 2017.

NuVasive increased its focus on the $2.5 billion deformity market in May 2015 with the launch of its Integrated Global Alignment® (iGA®) platform and RELINE® posterior fixation system. In February 2016, NuVasive expanded its footprint into the early onset scoliosis market with the addition of its industry-leading MAGEC® system, which utilizes innovative magnetic technology within adjustable growing rods. Today, NuVasive has the fastest growing spinal deformity portfolio and is expanding its support of key programs to drive improved clinical and economic outcomes. NuVasive recently launched the ‘Embracing the Journey Together‘ program, which includes pediatric spinal deformity research, education and spinal deformity event support, supporting leading surgeons as they educate surgeons around the world.

“At NuVasive, we remain laser-focused on transforming the lives of patients through disruptive innovation and support of clinical education and research,” said Greg Lucier, NuVasive chairman and chief executive officer. “We’ve made tremendous gains in adult and pediatric spinal deformity innovation, with the versatile RELINE portfolio and MAGEC system. With the upcoming launch of the RELINE Small Stature system available this summer, I’m confident in our ability to outpace the market. We’re proud NuVasive has taken the lead in supporting key global initiatives designed to help improve the lives of patients around the world.”

Part of the Company’s investment into pediatric spinal deformity care includes funding research and patient initiatives, such as the Harms Study Group and its Setting Scoliosis Straight Foundation, as the exclusive sponsor of the Power Over Scoliosis event. NuVasive is also providing research funding for the Children’s Spine Study Group and the Growing Spine Study Group.

NuVasive was a key sponsor of EPOSNA 2017, the combined meeting of EPOS and POSNA, held earlier this month in Barcelona, Spain. In July, NuVasive is the leading sponsor of IMAST 2017, the International Meeting on Advanced Spine Techniques hosted by the Scoliosis Research Society. The Company is also the leading sponsor of ICEOS, the International Congress of Early-onset Scoliosis, in November.

The Company also announced the launch of a monthly podcast series, MAGEC Matters, featuring interviews with leading surgeons in pediatric deformity discussing tips for the treatment of early onset scoliosis, which is now available on iTunes, SoundCloud and other leading podcast platforms.

Other events supported by NuVasive throughout 2017 include:

  • Setting Scoliosis Straight: Patient & Family Power over Scoliosis Educational Event
    June 2-3, 2017; Miami
  • Shriners Hospital for Children – Chicago “Early Onset Scoliosis and Management Strategies” Meeting
    June 9, 2017; Chicago
  • International Meeting on Advanced Spine Techniques (IMAST)
    July 12-15, 2017; Cape Town, South Africa
  • Scoliosis Research Society (SRS)
    Sept. 6-9, 2017; Philadelphia
  • Pediatric Orthopedic Surgical Techniques Lab (POST)
    Sept. 29-30, 2017; Memphis, Tenn.
  • International Congress of Early-onset Scoliosis (ICEOS)
    Nov. 16-17; 2017, San Diego
  • 2017 MAGEC Users Meeting
    Nov. 17-18, 2017; San Diego
  • International Pediatric Orthopaedic Symposium (IPOS)
    Nov. 28-Dec 2, 2017; Orlando, Fla.
  • Spina Bifida Association Walk-n-Roll Events
    Various U.S. cities throughout 2017

About NuVasive
NuVasive, Inc. (NASDAQ: NUVA) is a world leader in minimally invasive, procedurally-integrated spine solutions. From complex spinal deformity to degenerative spinal conditions, NuVasive is transforming spine surgery with innovative technologies designed to deliver reproducible and clinically proven surgical outcomes. NuVasive’s highly differentiated, procedurally-integrated solutions include access instruments, implantable hardware and software systems for surgical planning and reconciliation technology that centers on achieving the global alignment of the spine. With $962 million in revenues (2016), NuVasive has an approximate 2,300 person workforce in more than 40 countries around the world. For more information, please visit www.nuvasive.com.

Forward-Looking Statements
NuVasive cautions you that statements included in this news release that are not a description of historical facts are forward-looking statements that involve risks, uncertainties, assumptions and other factors which, if they do not materialize or prove correct, could cause NuVasive’s results to differ materially from historical results or those expressed or implied by such forward-looking statements. The potential risks and uncertainties which contribute to the uncertain nature of these statements include, among others, risks associated with acceptance of the Company’s surgical products and procedures by spine surgeons, development and acceptance of new products or product enhancements, clinical and statistical verification of the benefits achieved via the use of NuVasive’s products (including the iGA®platform), the Company’s ability to effectually manage inventory as it continues to release new products, its ability to recruit and retain management and key personnel, and the other risks and uncertainties described in NuVasive’s news releases and periodic filings with the Securities and Exchange Commission. NuVasive’s public filings with the Securities and Exchange Commission are available at www.sec.gov. NuVasive assumes no obligation to update any forward-looking statement to reflect events or circumstances arising after the date on which it was made.

 

SOURCE NuVasive, Inc.

Related Links

http://www.nuvasive.com

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ReconSpine

Forbes Names The DeAngelis Group Among the Top 250 Best Executive Recruiting Firms in 2017

May 19, 2017 OrthoSpineNews

SCOTTSDALE, ARIZONA (PRWEB) MAY 19, 2017

The De Angelis Group, the largest search firm dedicated solely to the orthopedic industry was named amongst the top 250 “Best Executive Recruiting Firms” listed by Forbes for 2017. The recent article was published on http://www.forbes.com on May 3, 2017, written by Jeff Kauflin.

Forbes worked with analytics firm Statista to compile a list of 4,000 executive recruiting companies. They then asked thousands of recruiters, employees who have worked with recruiting companies and H.R. managers to take an online survey, and recommend up to 10 recruiting firms (excluding their own). With over 20,000 recommendations, each company was then ranked by the highest number of recommendations.

The De Angelis Group is proud to have been named on the 2017 Forbes list and looks forward to continually working hard to bring value to the orthopedic industry. The De Angelis Group’s Managing Partner, Drue De Angelis said after receiving the news “It is an honor to be recognized for this distinction but what truly compels us is helping drive enterprise value for the companies and investors who entrust us with their most critical executive hires.”
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About The De Angelis Group

Founded in 2000 with one thing in mind; driving enterprise value for Orthopedic Start-up companies. The DeAngelis Group works with many of the most innovative and exciting new companies in the early stages of development to build a Talented Leadership Team.Whether your company is new to the space or you require a turn-around, our consultants first gain a solid grasp of the deliverables and the specific experience that the leader will require and then conduct the search effectively and timely.  Our network in Orthopedics is vast and qualitative. We have developed algorithms to evaluate who best fits in the start-up environment and who can develop and execute a strategic plan achieving sustainable growth.

Visit The De Angelis Group’s website 

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RegulatoryTop Stories

FDA Clears Iovera Cold Treatment Device for Knee OA Pain

May 19, 2017 OrthoSpineNews

Megan Brooks, Medscape – May 18, 2017

The US Food and Drug Administration (FDA) has cleared the iovera device, from Myoscience, Inc, for the relief of pain and symptoms associated with knee osteoarthritis (OA) for up to 90 days. Myoscience is located in Fremont, California.

“The iovera technology is a nonopioid and nonsystemic treatment for blocking pain signals from peripheral nerves,” the company said in a news release announcing FDA 51(k) clearance of the device.

The device uses the body’s natural response to cold to treat peripheral nerves. It consists of a hand piece equipped with a nitrous oxide cartridge and three closely spaced 27-gauge closed-end needle tips. The nitrous oxide flows from the cartridge to the needle tips, creating a highly localized cold zone. The effect is transient and provides pain relief until the nerve regenerates and its sensory function is restored.

“The iovera technology has the potential to change the current paradigm of pain management for osteoarthritis. The patients that I have treated with this technology have experienced immediate and long-lasting pain relief and are grateful to have an option that is nonnarcotic and nonsystemic,” Vinod Dasa, MD, member of the Myoscience medical advisory board, said in the release.

 

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Financial

DGAP-News: Curasan starts dynamically into the new year

May 19, 2017 OrthoSpineNews

Kleinostheim, 18 May 2017 – curasan AG (ISIN DE0005494538), a leading specialist for medical products in the field of orthobiologics, has continued to grow dynamically at the start of the year. Gross sales increased by 15.9 percent to EUR 1.89 million (Q1 2016: EUR 1.62 million). Earnings before interest, taxes, depreciation and amortization (EBITDA) improved by 3.4 percent (Q1 2016: -0.45 m EUR), while earnings before interest and taxes (EBIT) remained virtually unchanged at -0.45 million euros (Q1 2016: -0.45 m euros). However, due to lower interest expense, the net result rose slightly as well by 8.7 percent to -0.46 million euros (Q1 2016: -0.50 m euros).

The consideration of the sales performance according to regional aspects shows that the clear growth of almost all regions was dynamically supported. In Europe, sales rose by 10.6 percent to EUR 0.66 million, in MENA sales more than doubled, rising by 128.6 percent to EUR 0.26 million. In Asia, growth was 7.6 percent, with sales of a total of EUR 0.40 million, while the US markets increased by 7.7 percent to EUR 0.46 million.

Cash and cash equivalents decreased by 78.7 percent to EUR 0.21 million (31.12.16: 1.01 EUR) as of the balance sheet date, whereas trade receivables increased by 11.6 percent to 2.35 million Euro (31.12.16: 2.11 mEUR). At the same time, trade payables rose by 22.2 percent to EUR 1.05 million (31.12.16: 0.86 mEUR). Shareholders’ equity fell by 4.8 per cent to EUR 8.52 million, compared to EUR 8.95 million as of the end of 2016.

“We have shown a strong first quarter and our sales are growing across the board in all regions,” explains Michael Schlenk, CEO of curasan AG. “As projected, we will continue to invest heavily in marketing and registrations for this growth. Since the beginning of the second quarter and under the direction of the Finance Department by our new CFO, Christine Uekert, we are also taking a new approach in terms of our receivables management as well as the working capital and achieving good success here.” In addition, the company announced, with the publication of the 2016 Annual Report, that a capital increase would be implemented in the current financial year. “Our dynamic and sustainable growth is well recognized by institutional investors as well as strategic ones. A good basis for a further growth financing”, Schlenk adds.

Further details on the quarterly figures published today as well as current developments in the second quarter will be discussed by the CEO today at 2.00 pm in the course of an open telephone conference for analysts, qualified investors and journalists. You can register by e-mail via the Investor Relations and Corporate Communications departments (IR@curasan.com).

The complete report on the first quarter of 2017 has been made available by curasan on the Company’s website at the following link:

www.curasan.de/investoren/publikationen/finanzberichte

Contact curasan AG:
Ingo Middelmenne
Head of Investor Relations
+49 6027 40 900-45
+49 174 90 911 90

ingo.middelmenne@curasan.com

Andrea Weidner
Head of Corporate Communications
+49 6027 40 900-51
andrea.weidner@curasan.com

About curasan AG:

curasan develops, manufactures and markets biomaterials and medical devices in the field of bone and tissue regeneration, wound healing and osteoarthritis therapy. As a pioneer and global technology leader in the growing field of regenerative medicine, curasan is specialized primarily on biomimetic bone grafting materials for dental, oral/maxillofacial, orthopedic and spinal applications, i.e. materials mimicking biological structures. Numerous patents and a broad record of scientific publications demonstrate the clinical success of the products and the highly innovative strength of curasan. Dental and orthopaedic clinicians worldwide benefit from the broad range of the premium quality and easy to use portfolio offered by the technology leader curasan. curasan maintains its own high-tech facilities for research, development and manufacturing of biomaterials in Frankfurt/Main, Germany. In addition to its headquarters, the company has a subsidiary, curasan, Inc., in the Research Triangle Park area, near Raleigh, N.C., USA. curasan’s innovative products are cleared by the US Food and Drug Administration (FDA) and many other international authorities and available in almost 50 countries worldwide. curasan AG is a public company listed in the General Standard at the Frankfurt Stock Exchange.

18.05.2017 Dissemination of a Corporate News, transmitted by DGAP – a service of EQS Group AG.

The issuer is solely responsible for the content of this announcement.

The DGAP Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases.

Archive at www.dgap.de
Language: English
Company: curasan AG
Lindigstraße 4
63801 Kleinostheim
Germany
Phone: 06027/40 900 0
Fax: 06027/40 900 29
E-mail: info@curasan.de
Internet: www.curasan.de
ISIN: DE0005494538
WKN: 549453
Listed: Regulated Market in Frankfurt (General Standard); Regulated Unofficial Market in Berlin, Dusseldorf, Hamburg, Munich, Stuttgart, Tradegate Exchange

 
End of News DGAP News Service
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BiologicsFinancialTop Stories

Florida Institute Funds Alachua-based Amend Surgical

May 19, 2017 OrthoSpineNews

GAINESVILLE, Fla. and BOCA RATON, Fla., May 18, 2017 /PRNewswire-USNewswire/ — The Florida Institute for the Commercialization of Public Research (the Florida Institute) announced today that it has finalized a funding agreement with Amend Surgical, an Alachua-based medical device company with newly licensed technology developed at the University of Florida. The Florida Institute supports new company development and expansion based on publicly-funded research, and bridges early funding gaps for companies licensing technology out of Florida-based universities and research institutions.

Amend Surgical is a specialty medical device company focused on enhancing the healing and regenerative capacity of bone grafts, including allograft, xenograft tissues and synthetic materials. The company’s pipeline includes novel, osteoinductive bone extracts, and will expand in the future to disruptive products based on discovery and development of novel therapeutic additives with tissue-specific regenerative characteristics.

“We are committed to advancing the science of orthobiologics by improving the healing capacity of bone grafts.  The new funding agreement with the Florida Institute will allow Amend to rapidly expand our research and commercialization efforts on Biomimetic Bone which was licensed from the University of Florida in March 2017,” said Robby Lane, Chief Executive Officer of Amend Surgical.

“Amend Surgical provides surgeons and their patients access to innovative bone grafting options,” said Jackson Streeter, MD, Florida Institute Chief Executive Officer. “By developing and advancing bone grafts and other orthobiologics with enhanced regenerative capacity, surgery patients can identify, with guidance from their physicians, new options that can help them achieve the best possible surgical outcomes.”

About the Florida Institute

Formed by the Florida Legislature in 2007, the Florida Institute for the Commercialization of Public Research is a non-profit organization that works collaboratively with the technology licensing and commercialization offices of Florida’s state universities and private research institutions to leverage a $2.5B+ research base and form investable companies that create clean jobs in new industries that are driving the global economy. With funding from the State of Florida through the Department of Economic Opportunity, and through the generosity of mentors, advisors and donors, the Florida Institute provides company building services, and seed funding through the Florida Technology Seed Capital Fund, to promising Florida startups. Sixty-nine companies have been funded to date, and the Florida Institute’s economic impact through June 30, 2016 in the State of Florida was $630 million.

About Amend Surgical

Amend Surgical is a product development company offering differentiated biologic solutions for surgeons, medical device manufacturers and distributors globally.  Amend is targeting the bone graft substitute market with licensed, patented, technology and is focused on spine, orthopedic and dental indications.  The R&D pipeline includes products loaded with antibiotics and natural bone morphogenic proteins. Additionally, Amend is commercializing a novel Biomimetic Bone technology licensed from the University of Florida that offers the hope for a synthetic graft with load bearing capability and osteostimulative properties.  Amend currently manufactures and distributes the only demineralized bone-bioactive glass combination product approved by the FDA. NanoFUSE® Bioactive Matrix uniquely combines the osteoinductive capabilities of demineralized allograft bone with the osteostimulative properties of 45S5 bioactive glass.

CONTACT:
Jane Teague
Chief Operating Officer
Institute for the Commercialization of Public Research
561-368-8889
jane.teague@florida-institute.com

 

SOURCE Florida Institute for the Commercialization of Public Research

Related Links

http://www.florida-institute.com

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