Regentis Receives IDE Approval for Pivotal GelrinC Clinical Trial

Posted On September 26, 2016 By OrthoSpineNews In Regulatory /

Princeton, NJ and Or Akiva, Israel, September 26 — Regentis Biomaterials, a developer of hydrogels for tissue regeneration, announced it has received U.S. Food and Drug Administration (FDA) Investigational Device Exemption (IDE) approval to initiate a pivotal Phase III clinical study of GelrinC, a novel treatment for focal cartilage defects in the knee. This clinical study will be used to support a Premarket Approval Application (PMA) which will allow Regentis to market GelrinC in the U.S.

The cartilage repair market is the largest unmet need in orthopedic sports medicine today, and represents an estimated market opportunity of more than US $1 billion. Articular cartilage is the smooth, white tissue covering the ends of bones where they come together to form joints. Cartilage has limited ability to repair itself, which means that surgical intervention is often required. Focal defects typically occur as a result of trauma and are extremely painful to the patient. Microfracture, the standard of care procedure, provides only short-term relief to patients and often requires additional surgical intervention.

“Gaining IDE approval is a significant step forward for Regentis and brings us that much closer to helping US patients recover from damaged articular knee cartilage,” said Regentis President and CEO Alastair Clemow. “GelrinC has been shown to effectively regenerate high quality cartilage, a key challenge in treating these kinds of knee injuries. GelrinC has already demonstrated excellent clinical outcomes in our European study, and we look forward to substantiating these results in the U.S.”

The GelrinC procedure is easy and quick for surgeons to perform and can be carried out using a minimally invasive approach. It is administered as a liquid allowing it to fill any size and shape of defect, making it suitable for all lesion types. After a short exposure to ultra-violet light, GelrinC is converted into a solid implant completely filling in the lesion. The implant naturally degrades within 6-12 months and is gradually replaced with functional and durable cartilage.

“GelrinC is a potential game changer in the cartilage repair space, and can be an attractive and viable option for patients,” said Dr. Brian J. Cole, Associate Chairman and Professor within the Department of Orthopedics at Rush University Medical Center in Chicago. “GelrinC has promising clinical outcomes to date and the pre-clinical work is very supportive.”

This FDA trial will evaluate the safety and efficacy of GelrinC compared to the raw level data of a historical microfracture control arm. The study design overcomes the limitation of randomized control studies in this field, which is expected to result in faster patient enrollment and significantly reducing the time for product approval.

About Regentis Biomaterials

With offices in Or Akiva, Israel and Princeton, NJ, Regentis Biomaterials is a privately held company focused on developing and commercializing proprietary hydrogels for tissue regeneration. The company’s core technology is a biodegradable hydrogel called Gelrin™. It is based on polyethylene glycol diacrylate and denatured fibrinogen originally developed at the Technion – Israel Institute of Technology by Dr. Dror Seliktar. The Gelrin hydrogel platform combines the stability and versatility of a synthetic material with the bio-functionality of a natural substance for a range of clinical applications. For more information, please visit www.regentis.co.il.
For media inquiries, please contact:

Josh Turner

Media Relations

Phone: 917-231-0550

josh@jtpublicrelations.com

Alastair Clemow, PhD

President & CEO

1-508-930-8865

International Cartilage Repair Society Symposia To Highlight Early Findings Of Prochondrix Cartilage Restoration Matrix

Posted On September 23, 2016 By OrthoSpineNews In Biologics /

CENTENNIAL, Colo., Sept. 23, 2016 /PRNewswire-USNewswire/ — AlloSource, one of the nation’s largest providers of cartilage, cellular, bone, skin and soft-tissue allografts for use in surgical procedures and wound care to advance patient healing, will share early results of its fresh cartilage allograft, ProChondrix® Cartilage Restoration Matrix during the International Cartilage Repair Society’s (ICRS) 13^th World Congress in Sorrento-Naples, Italy. The Industry Satellite Lunch Symposia will take place on Monday,26 September 2016 from 13:00 to 13:30 in the Sala Nettuna Room.

Vishal Mehta, M.D., orthopedic surgeon from Fox Valley Orthopedics in Geneva, Illinois, will present early results of ProChondrix transplantation on isolated articular cartilage defects. Patients underwent treatment of an isolated, symptomatic articular cartilage surface lesion, which was treated with microfracture and placement of a ProChondrix graft. The 12-month review post-treatment demonstrated early success and no failures. In addition to Dr. Mehta, Laurie Goodrich, D.V.M, Ph. D., associate professor in equine surgery and lameness at Colorado State University, will share the findings of a 12-month horse study.

“Clinical information is an important piece of the puzzle when finding products to help heal my patients,” said Dr. Vishal Mehta, orthopedic surgeon. “I am excited by the promising early results of my first patients who received ProChondrix.”

AlloSource will also present several posters at ICRS. One will focus on Dr. Mehta’s 12-month clinical results, another highlights Dr. Goodrich’s equine study findings, both previously mentioned, and another poster shares results from an internal study on ProChondrix’s likeness to healthy adult cartilage. The internal study found ProChondrix, a fresh cartilage allograft, inherently matches the biomechanical and biochemical properties of normal hyaline cartilage found in a healthy adult, proving it is a viable solution to help restore articular cartilage surfaces, relieve patient symptoms and improve function.

For more information on ProChondrix and the recently launched Reimbursement Hotline dedicated to assisting customers and providing information on coding options, coverage access and reimbursement, please visit ProChondrix.org.

About AlloSource
AlloSource is one of the largest nonprofit cellular and tissue networks in the country, offering more than 200 types of precise cartilage, cellular, bone, skin and soft-tissue allografts to advance patient healing. For more than 20 years, AlloSource’s products have bridged the proven science of allografts with the advanced technology of cells, offering life-saving and life-enhancing possibilities in spine, sports medicine, foot and ankle, orthopedic, reconstructive, trauma and wound care procedures. As the world’s largest processor of cellular bone allografts, fresh cartilage tissue for joint repair and skin allografts to help heal severe burns, AlloSource delivers unparalleled expertise and service to its growing network of surgeons, partners, and the country’s most reputable organ procurement organizations. The company is accredited by the American Association of Tissue Banks and is headquartered in Centennial, CO. For more information, please visit allosource.org or our educational website,allograftpossibilities.org.

Media Contact
Megan Duggan
AlloSource
720. 382. 2766
mduggan@allosource.org

SOURCE AlloSource

Related Links

http://www.allosource.org

SPINEWAY SIGNS A PARTNERSHIP DEAL WITH TINAVI MEDICAL TECHNOLOGIES

Posted On September 23, 2016 By OrthoSpineNews In Financial /

TINAVI Medical Technologies is a Beijing-based group specializing in innovative medical devices. The company is a provider of avant-garde surgical systems and operating theatre solutions. Its third generation intelligent orthopedic robot, the TiRobot(TM), is the only surgical robot in the world capable of performing surgery on all areas of the spine (cervical, thoracic, lumbar, and sacral vertebrae). The company has been listed on Beijing’s NEEQ Stock Market since November, 2015.

This agreement will, from 2016 onwards, enable TINAVI Medical Technologies to distribute SPINEWAY implant ranges that are registered in China.

In this context, before the end of 2016, SPINEWAY will propose a capital increase to its shareholders. The capital increase would be made by way of issuance of shares with stock subscription warrants attached (BSA) reserved entirely to TINAVI Medical Technologies, with shareholders pre emption rights waived, for an amount of 1.399.724.40 EUR (including share premium).

The transaction will involve the issue of 355,260 new shares at a price of 3.94 EUR each, giving TINAVI Medical Technologies 9.09% share of the capital and 5.04% of voting rights.

A stock subscription warrant will be attached to each of these newly issued shares, with 10 stock subscription warrants giving the right to subscribe to 11 additional new shares at a unit price of 4.09 EUR each, representing a total of 390,786 additional new ordinary shares, representing a further maximum subscription of 1,598,314.74 EUR (share premium included). These stock subscription warrants may be exercised from 1^st June to 15^thSeptember, 2017. After this second tranche, if the issue is taken up completely, TINAVI Medical Technologies’ stake will account for 17.36% of the capital and 10.59% of voting rights.

The agreement also provides that TINAVI Medical Technologies be granted a priority right on any future financial transaction SPINEWAY might initiate, as well as the right to maintain its shareholding at the same level as provided for in the aforementioned capital increase transactions.

The agreement furthermore provides the appointment of TINAVI Medical Technologies or one of its representative as an observer to the board of directors, as the case may be, the appointment of TINAVI Medical Technologies or one of its representative as director in the event of the whole of the second investment tranche being taken up.

TINAVI Medical Technologies’ subscription undertaking is subject to a certain number of usual conditions for such kind of transaction.

This operation enjoys the support of Messrs Le Roux and Laurito, key, long-standing shareholders of SPINEWAY, who hold together 87.03% of the company voting rights. They have committed to vote in favor of all the resolutions related to this transaction, which will be submitted to the next extraordinary shareholders’ meeting.

For SPINEWAY CEO Stéphane Le Roux, “This new agreement opens up new prospects for SPINEWAY. I’d like to thank Mr. Zhang Songgen, whose group will become a key shareholder, for the confidence shown in our company and our know-how. Our Chinese deployment will now revolve around a front-stage actor, recognized worldwide for its innovation in the orthopedics field.”

TINAVI CEO Mr. Zhang Songgen states, “We are delighted to announce a new strategic partnership between our company, TINAVI Medical Technologies, and SPINEWAY, which will bring new, additional therapies to the world of spinal surgery. By combining our expertise, we shall bring in innovations on a worldwide scale that will be decisive for surgeons specializing in problems and diseases of the vertebral column.”

Contacts :


Investor relations David Siegrist – CFO Tél : +33 (0)4 72 77 01 52 finance.dsg@spineway.com		Financial communications Jérôme Gacoin / Solène Kennis Tel : +33 (0)1 75 77 54 68 skennis@aelium.fr

SPINEWAY signs a partnership deal with TINAVI Medical Technologies
Sep 22, 2016

Los Angeles Orthopedic Surgeon Scheduled to Perform First Bone Anchored Prosthesis Surgery in Southern California

Posted On September 23, 2016 By OrthoSpineNews In Extremities /

Los Angeles, CA (PRWEB) September 19, 2016

Dr. Daniel C. Allison, a board-certified orthopedic surgeon in Los Angeles specializing in orthopedic oncology, anterior hip replacement, and joint reconstruction, has announced that he is scheduled to perform the first bone anchored (osteointegrated) prosthesis surgery in Southern California. The patient is a former police officer with an above-the-knee amputation.

“We are very excited to be the first practice in Southern California to offer the surgery,” said Dr. Allison. “We make limb preservation a priority for our soft tissue and bone sarcoma patients, and are constantly working to bring the latest surgical innovation techniques to our joint replacement and hip arthroplasty treatments for both adult and pediatric patients.”

Traditional prosthetics use a ball and socket design. The socket is placed around the end of the affected limb, to which the prosthetic arm or leg is then attached. While this approach is highly effective in many cases, it requires enough surface area on the remaining limb to adequately attach the cap with the socket. It can also present issues with comfort and fit.

The Osseoanchored Prosthesis for the Rehabilitation of Amputees (OPRA), which has been approved by the FDA (Food and Drug Administration) for use in above the knee amputees, implants a titanium fixture directly into the bone. Once the fixture has integrated and healed, a rod is attached through the skin, which then connects to the prosthetic leg. The benefits of this approach include greater mobility, range of motion, and comfort. It also offers hope for amputees who are not good candidates for or have had limited success with traditional socket prosthetics. Using a titanium implant helps to mitigate the risk of rejection from the bone.

Learn about bone anchored prosthesis: http://www.DrAllison.org/Bone-Anchored-ProstethisOsteointegrated-OI-Prosthesis/

“With proper care and comprehensive physical therapy and rehabilitation, we are very optimistic that this approach will offer a significant improvement in quality of life for many adults, especially veterans and members of law enforcement like our patient, with above-the-knee amputations,” added Dr. Allison.

About Daniel C. Allison, MD, FACS.

Daniel C. Allison, MD, FACS, MBA, is board certified in orthopedic surgery with expertise in musculoskeletal oncology, joint reconstruction, and anterior hip replacement. He is Assistant Director of Orthopedic Oncology, Cedars-Sinai Sam Oschin Cancer Center. Dr. Allison is a fellow of the American College of Surgeons and the American Academy of Orthopedic Surgeons. As an orthopedic oncologist, Dr. Allison is a recognized leader in malignant problems of the musculoskeletal system, including soft tissue and primary sarcomas of the bone, invasive metastatic bone cancer, and invasive skin cancers of the back, pelvis, shoulder girdle, and extremities.

For more information about us, please visit http://www.DrAllison.org/

Daniel C. Allison, MD FACS
444 S San Vicente Blvd #603
Los Angeles, CA 90048
info(at)DrAllison(dot)org

Anika Announces Data Presentations on HYALOFAST Hyaluronic Acid-Based Scaffold at 2016 World Congress of the International Cartilage Repair Society

Posted On September 23, 2016 By OrthoSpineNews In Biologics /

September 22, 2016

BEDFORD, Mass. & NAPLES, Italy–(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 four data presentations on HYALOFAST, a biodegradable HA-based scaffold, at the 13^th World Congress of the International Cartilage Repair Society (ICRS). The ICRS World Congress, which is being held in Sorrento, Naples, Italy during September 24-27, 2016, is the world’s largest gathering of scientists, clinicians and industry participants focused on clinical cartilage repair and basic cartilage research.

“We’re proud to showcase the results of four recent and important studies evaluating the clinical utility of our biodegradable scaffold, HYALOFAST, before an audience of world-renowned experts in the field of cartilage repair and regeneration. Collectively, the data reinforce the significant advantages HYALOFAST offers over invasive surgical interventions and traditional scaffolds, specifically in terms of ease of use, efficiency and positive treatment outcomes,” said Charles H. Sherwood, Ph.D., President and Chief Executive Officer, Anika Therapeutics. “In addition, at our booth this year, we’re excited to debut the HYALOFAST Virtual Simulator, a digital training tool exclusively designed to allow physicians to experience a guided simulation of the entire HYALOFAST procedure in virtual reality.”

HYALOFAST is a non-woven biodegradable hyaluronic acid-based scaffold for hyaline-like cartilage regeneration to treat cartilage injuries and defects. HYALOFAST is commercially available in over 15 countries and has been used in more than 7,000 patients to date. HYALOFAST is pending regulatory submission in the United States and its ‘FastTRACK’ Phase III trial is currently enrolling patients across the U.S. and Europe.

HYALOFAST Data and Poster Presentations
Sunday, September 25, 2016

1. One-stage Cartilage Repair using Hyaluronic acid-based Scaffold and Mesenchymal Stem Cells (HA-BMAC) Compared to Microfracture: 5 Year FU (Authors: A. Gobbi, G. Whyte, B. Sadlik)
2. Arthroscopic Cartilage Repair using a Hyaluronic Acid-based Scaffold and Activated Bone Marrow-derived Mesenchymal Stem Cells (HA-BMAC) (Authors: G. Whyte, A. Gobbi, B. Sadlik)
3. Medium-term Outcomes of Cartilage Repair using Hyaluronic acid-based Scaffold with Multipotent Stem Cells in Patients Over 45 Years of Age (Authors: A. Gobbi, G. Whyte, M. Castro, B. Sadlik)

Monday, September 26, 2016

1. Hyaluronic acid-based scaffold versus bilayer collagen scaffold in patellofemoral chondral defect repair using dry arthroscopy(Authors: M. Puszkarz, B. Sadlik, A. Gobbi, M. Wiewiorski, B. Gaj, W. Klon, G. Whyte)

Company-Sponsored Symposia
Sunday, September 25, 2016

1. Hyalofast: One Step Cartilage Regeneration From Trauma To Early Degenerative Lesions
Moderators: Dr. Francesca Vannini (Rizzoli Institute – Bologna –Italy) and Dr. Boguslaw Sadlik (St. Luke Clinic – Bielsko-Biala –Poland)
Speakers: Dr. Brunella Grigolo (Rizzoli Institute – Bologna –Italy), Prof. Roberto Buda (Rizzoli Institute – Bologna –Italy), Prof. Alberto Gobbi (O.A.S.I. Bioresearch Foundation – Milan –Italy)

Conference Location: Hilton Sorrento Palace, Sorrento – Naples, Italy
Anika Booth: # 6

About ICRS
The ICRS (International Cartilage Repair Society) is the main forum for international collaboration in cartilaginous tissue research that brings together basic scientists, clinical researchers, physicians and members of industry, engaged or interested in the field of articular biology, its genetic basis and regenerative medicine. It provides continuing education and training to physicians and scientists with an active interest in the prevention and treatment of joint disease to improve patient care through regenerative medicine approaches.

About Anika Therapeutics, Inc.
Anika Therapeutics, Inc. (NASDAQ: ANIK) is a global, integrated orthopedics medicines company based in Bedford, Mass. Anika is committed to improving the lives of patients with degenerative orthopedic diseases and traumatic conditions by providing clinically meaningful therapeutic pain management solutions along the continuum of care, from palliative care to regenerative medicine. The Company has over two decades of expertise developing, manufacturing and commercializing more than 20 products, in markets across the globe, based on its proprietary hyaluronic acid (HA) technology. Anika’s orthopedic medicine portfolio is comprised of marketed (ORTHOVISC^® and MONOVISC^®) and pipeline (CINGAL^® and HYALOFAST^® in the U.S.) products to alleviate pain and restore joint function by replenishing depleted HA and aiding cartilage repair and regeneration. For more information about Anika, please visit http://www.anikatherapeutics.com.

Forward-Looking Statements

The statements made in the third 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 enrollment of patients in the Hyalofast clinical trial and the U.S. regulatory submission associated with Hyalofast. 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, including for Hyalofast, 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

le-futur-siege-de-medicrea-est-en-construction-route-de-strasbourg-a-vancia-photo-dr-1458075822.jpg

Medicrea Announces Results for the 1st Half of 2016

Posted On September 23, 2016 By OrthoSpineNews In Financial /

September 22, 2016

LYON, France & NEW YORK–(BUSINESS WIRE)–The Medicrea Group (Paris: ALMED) (Alternext Paris: FR0004178572 – ALMED), pioneering the development and manufacture of personalized analytical services and implant solutions for the treatment of complex spinal conditions, announced 2016 half-year results to June 30, approved by the Board of Directors on September 19, 2016.


€ millions	H1 2015		H1 2016
Revenue	13.8		14.8
Gross margin as a % of sales	79	%	81	%
Operating profit before amortization and provisions	0.5		0.6
Operating profit before share-based payments	(1.0	)	(1.5	)
Other non-recurring expenses	(0.1	)	(1.2	)
Current pre-tax profit	(1.1	)	(2.9	)
Net profit	(1.0	)	(2.7	)

The variations in exchange rate had no significant impact on results

H1 2016 revenue rose by 1 million euros, up 7% compared to the same period of 2015, driven by growth of +20% in France, the Group’s historic market, and +13% in the US, a priority market that represents over 60% of sales.

Gross margin improved by 2 points compared to the first half of 2015 to reach €12 million, or 81% of revenues. This evolution of the gross margin reflects both the relevance of the industrial strategy and modernization of production means, in which Medicrea has invested heavily since 2014, as well as the growing importance of the US market in sales revenues. To further control the gross margin, the Group is gradually changing its international distribution strategy to favor a direct market presence by opening new subsidiaries and signing cooperative agreements with its distributors.

“We are continuing our investment policy and increasingly intensifying our research and development efforts to promote our UNiD™ personalized spinal technology and services in the US and worldwide. The sales and marketing teams have been expanded notably with the establishment of our subsidiary in Germany, whose contribution to Group revenue will not be seen substantially until 2017. Despite these significant costs, our operating income before depreciation and amortization remains positive, a slight increase over last year to 0.6 million euros,” stated Denys Sournac, President and CEO.

In the first half of the year, an exceptional expense of €1.2 million was generated by the collective costs relating to the relocation of the production unit from La Rochelle to Lyon, France. The new facilities, which will group the production teams with research and development, sales and administrative support, will be operational in the 4th quarter of 2016.

In August, Medicrea raised €20 million in financing, which consisted of €15 million in convertible bonds, held by Athyrium Capital Management, a US investor strongly regarded as a specialist in the sector, and €5 million in equity through a private placement, in which Denys Sournac, President and CEO, and Richard Kienzle, co-founder of Globus who joined the Medicrea Group at this time, participated.

“The appointment of Richard Kienzle, as Chief Commercial and Business Development Officer, highlights his confidence in Medicrea’s unique opportunity in the marketplace and marks a new milestone in the Group’s history. The proven industry experience that Richard Kienzle brings, combined with the significant resources provided as part of the fundraising, enables Medicrea to secure our position as a pioneer and worldwide leader in personalized spine and to become a key player in the complex spine market,” continued Denys Sournac.

The milestone of 1,000 UNiD™ surgeries is expected in the 4th quarter, with nearly half of those surgeries to take place in the United States where the technology’s adoption has accelerated markedly in recent months.

Next publication: Sales for the 3^rd quarter of 2016 published October 6, 2016, after market.

About Medicrea (www.medicrea.com)

Medicrea specializes in the design, manufacture, and distribution of innovative proprietary technologies devoted exclusively to spinal surgery. Operating in a $10 billion market, Medicrea operates with 150 employees, including 40 at its Medicrea USA Corp. subsidiary based in New York City.

Medicrea is the only company to offer personalized value-based healthcare solutions to the global complex spine market. The Company has driven innovation in Spine by focusing development on market-disrupting technologies focused on patient outcomes, including the growing UNiD™ Technology Platform of Patient-Specific Implants and Analytical Services, which received the first-ever FDA Clearance in November 2014 for a personalized spinal treatment modality.

Medicrea has uniquely positioned itself outside of the traditional implant manufacturer’s role in order to engage with each market player as a collaborator, offering customized implants to patients, personalized services to doctors and immediate cost-savings to providers. By leveraging its proprietary software analysis tools with big data technologies, Medicrea is well-placed to improve the efficacy of spinal care efficiency for all stakeholders in this market.

Connect with Medicrea:

FACEBOOK | INSTAGRAM | TWITTER | WEBSITE | YOUTUBE

Medicrea is listed on ALTERNEXT Paris ISIN : FR 0004178572 – Ticker : ALMED

Contacts

Medicrea
Denys Sournac, +33 (0)4 72 01 87 87
Founder, Chairman and CEO
dsournac@medicrea.com
or
Fabrice Kilfiger, +33 (0)4 72 01 87 87
Chief Financial Officer
fkilfiger@medicrea.com

Spineology Inc. Expands Relationship with Nation’s Leading Tissue Bank

Posted On September 23, 2016 By OrthoSpineNews In Spine /

September 23, 2016

MINNEAPOLIS & ST. PAUL, Minn.–(BUSINESS WIRE)–Spineology Inc., the innovator in anatomy-conserving spine surgery, announced today it has expanded its relationship with Musculoskeletal Transplant Foundation (MTF), the nation’s leading tissue bank. MTF will now be the sole tissue provider for Spineology’s allograft product lines, including the newly launched Incite™ Cortical Fibers, a unique and versatile bone grafting solution.

“MTF has a long track record of delivering safe, high quality tissue products using the most stringent standards in the industry,” said John Booth, CEO of Spineology Inc. “Our expanded relationship allows us to pass along that safety and quality to our customers.”

Incite Cortical Fibers are ultra-thin, entangled cortical bone fibers which provide a significant surface area of exposed growth factors to stimulate bone growth, and an osteoconductive matrix for cellular attachment and proliferation. The fibers also offer excellent handling properties, in-situ expansion and placement through a variety of delivery methods.

“The Incite Cortical Fibers give me great intra-operative flexibility because of the handling properties and versatility of the product,” said Charles C. Park, M.D., Ph.D., Director of the Minimally Invasive Brain and Spine Center at Mercy Medical Center in Baltimore, Maryland.

About Spineology Inc.
Spineology Inc. provides innovative, anatomy conserving spinal technologies for surgeons and their patients. Spineology surgical techniques conserve spinal bone, ligament and muscle tissue. Spineology is committed to increasing procedural efficiency, reducing surgical morbidity and accelerating patient recovery. Learn more at spineology.com.

Contacts

Spineology Inc.
John Booth, 651-256-8511
jbooth@spineology.com
or
Risdall Public Relations
Dave Folkens, 651-286-6713
dave@risdall.com

Implanet Announces Its 2016 First-Half Results: Buoyant Growth in Revenue and Substantial Gross Margin Improvement

Posted On September 23, 2016 By OrthoSpineNews In Financial /

September 23, 2016

BORDEAUX, France & BOSTON–(BUSINESS WIRE)–

IMPLANET (Euronext: IMPL, FR0010458729, PEA-PME eligible) (IMPL.PA) (OTCQX:IMPZY), a medical technology company specializing in vertebral and knee-surgery implants, today announces its financial results for the 1^st half of the year to June 30, 2016, as approved by the Board at its meeting of September 20, 2016.

In € thousands – IFRS	H1 2016	H1 2015
Revenue	4,094	3,307
Cost of products sold	-1,943	-2,173
Gross margin	2,152	1,134
Gross margin (%)	52.5%	34.3%
Research & Development	-532	-483
Regulatory matters, Quality control	-510	-472
Sales, distribution and marketing costs	-2,606	-2,283
Operating costs	-526	-398
General costs	-1,534	-1,773
Operating Profit/Loss	-3,556	-4,275
Net Profit/Loss	-3,802	-4,299

Revenue: further ramping up of Jazz in the United States and France

Over the 1^st half of 2016, the Group recorded revenue of €4.094 thousand, up 24% compared with the 1^st half of 2015, notably due to a further increase in Spine activity (+38% compared with H1 2015). This growth momentum was a direct result of Implanet’s growth in the United States and France, markets in which Implanet markets its Jazz technological platform directly and where sales increased by 101% and 40% respectively. Close to 800 surgical interventions were carried out using the Jazz technological platform in the 1^st half of 2016, taking the total number of patients treated via this technology to more than 2,800 since its launch in 2013 (with more than 15,000 implants in total).

The substantial acceleration in the number of surgical operations carried out reflects the growing adoption of Jazz technology by surgeons around the world (111 surgeons as of June 30, 2016), notably due to the excellent clinical results obtained by Jazz in adults and adolescents and the growing use of Jazz technology on the degenerative bone disorder segment, the largest market segment.

Knee activity recorded a 12% increase in sales to €2.1 million over the first six months of the year. As anticipated, this increase was driven by the particularly buoyant growth of over 50% on the French market, which now accounts for over 70% of this division’s revenue.

Strong increase in the gross margin, tight control of the operational structure

In the 1^st half of 2016, the gross margin came to 52.5% of revenue, a substantial improvement of 18.2 percentage points. This is a direct result of the increase of Jazz sales in the United States, the market with favorable unit sale prices and an excellent overall product and geographic mix.

The €302 thousand increase in operating expenses compared with the 1^st half of 2015 was mainly due to the €323 thousand increase in sales and marketing costs that accompanied the buoyant growth in activity, in particular in the United States (including €184 thousand in personnel costs following the strengthening of the sales team and the appointment of Brian T. Ennis to head the US subsidiary, as well as a €173 thousand in sales commissions paid to sales agents).

Other operating costs remained stable compared with the 1^st half of 2015, reflecting tight control over expenses.

Taking all these factors into account, Implanet recorded a 17% improvement in its operating result to -€3,556 thousand in the 1^st half of 2016 (vs. -€4,275 thousand in H1 2015) and a 12% improvement in its net loss to -€3,802 thousand (vs. -€4,299 thousand in H1 2015).

Cash, cash equivalents and financial investments

As of June 30, 2016, Implanet had cash and cash equivalents of €2.0 million and financial investments of €1.9 million, i.e. a total of €3.9 million. Operating cash burn was €3.5 million in the first half of 2016, versus €4.6 million in the first half of 2015 (giving a 24% reduction in cash burn).

Implanet also has the possibility to request, under certain conditions, the subscription of 340 convertible bonds coupled with equity warrants (OCABSA) with L1 EUROPEAN HEALTHCARE OPPORTUNITIES FUND for a total amount of €3.4 million, and recently obtained an interest-free innovation loan of €0.8 million from Bpifrance Aquitaine.

Ludovic Lastennet, CEO of Implanet, says: “Over the first half of this year, we have successfully continued to implement our growth strategy in our direct markets: France and the United States. This strategy prioritizes the following development routes: continue our expansion via the contribution of the new Jazz Claw implant for major deformities and Jazz Lock implant for degenerative bone disorders, demonstrate Jazz’s clinical efficacy through major clinical studies and continue improving our financial performance through the ramping up in the United States and tight control over our spending.”

TiGenix Appoints Dr. June Almenoff to its Board of Directors

Posted On September 23, 2016 By OrthoSpineNews In Biologics /

LEUVEN, Belgium, Sept. 22, 2016 (GLOBE NEWSWIRE) — TiGenix NV (Euronext Brussels: TIG), an advanced biopharmaceutical company focused on developing and commercializing novel therapeutics from its proprietary platforms of allogeneic expanded stem cells, today announced that it has appointed June Almenoff, M.D., Ph.D., as a member of its Board of Directors in replacement of Dirk Reyn.

“Her background is a perfect fit for TiGenix, and the projects we have under development. She has a strong clinical development record, and has successfully led the process toward FDA approval for a GI product; experience with early-stage development, scientific licensing and business development; an expertise in infectious diseases, and a clear focus on the US market,” said Eduardo Bravo, CEO, TiGenix. “With Cx601 close to start its second pivotal Phase III study towards BLA filing and the rest of the assets moving into mid to late stage clinical development, June is a great complement to our outstanding Board of Directors.”

“I am very excited to be joining the Board of TiGenix,” said Dr. June Almenoff. “TiGenix currently has the most advanced cell therapy pipeline in Europe, with positive pivotal Phase III data and European filing of their lead product candidate, Cx601, announced earlier this year. The product has then been licensed ex-US to Takeda. These are remarkable accomplishments. As a Board member, I look forward to leveraging my clinical development and regulatory experience with the FDA to move Cx601 along the pathway toward approval in the US, as well as to advance the company’s pipeline initiatives in acute myocardial infarction and severe sepsis.”

Dr. Almenoff is replacing Dirk Reyn (R&S Consulting BVBA), who is stepping down. “I regretfully leave my position at TiGenix due to my increasing commitment to eTheRNA immunotherapies, where I am CEO,” said Dirk Reyn. “During my five-year tenure as a Board member at TiGenix, together with the Management Team, we have transformed the company, secured funding from marquee investors and achieved the first ever positive pivotal trial with an allogeneic cell therapy product that led to the very successful licensing agreement with Takeda. I am very proud of the work we have done together.”

“We have made tremendous progress during Dirk’s tenure. We sincerely owe him our gratitude for his help getting us to where we are today” said Jean Stéphenne, Chairman of the Board of Directors of TiGenix. “As we march toward approval of Cx601 in the US and we advance our pipeline in new and exciting indications I am confident that Dr. June Almenoff, given her clinical development background and experience working with the FDA, is the ideal person for our Board going forward.”

June S. Almenoff MD, PhD, is an accomplished pharmaceutical executive with close to 20 years of industry experience. She has extensive expertise in clinical development, translational medicine and business development. Dr. Almenoff recently served as President, Principal Executive Officer and Chief Medical Officer of Furiex Pharmaceuticals, a publicly held biopharma company. During her 4-year tenure, the company’s valuation increased ~10-fold, culminating in its acquisition by Actavis plc (now Allergan) for ~$1.2B in 2014. Furiex’s lead product, eluxadoline (Viberzi TM), a novel gastrointestinal drug, received FDA approval in 2015. Prior to joining Furiex, Dr. Almenoff was at GlaxoSmithKline (GSK), where she held positions of increasing responsibility. During her 12 years at GSK, she was a Vice President in the R&D organization, chaired a PhRMA-FDA working group and also worked in the area of scientific licensing. Dr. Almenoff led the development of pioneering systems for minimizing risk in early- and late-stage drug development which are now widely used by pharmaceutical companies and regulatory agencies. Dr. Almenoff is currently an independent biopharma consultant and Board Director: she is the Executive Chair of RDD Pharma and a member of the Boards of Ohr Pharmaceuticals (Nasdaq: OHRP) and Valanbio. She also serves on the investment advisory board of the Harrington Discovery Institute (Case Western Univ.) and the advisory boards of Redhill Biopharma (Nasdaq: RDHL) and numerous private companies. Dr. Almenoff received her B.A. cum laude from Smith College and graduated with AOA honors from the M.D.-Ph.D. program at the Icahn (Mt. Sinai) School of Medicine. She completed post-graduate medical training at Stanford University Medical Center (Internal Medicine, Infectious Diseases) and served on the faculty of Duke University School of Medicine. She is an adjunct Professor at Duke and a Fellow of the American College of Physicians.

The appointment of June Almenoff is effective immediately subject to final appointment by the next shareholders’ meeting.

For more information

Claudia D’Augusta Chief Financial Officer

T: +34 91 804 92 64

claudia.daugusta@tigenix.com

About TiGenix

TiGenix NV (Euronext Brussels: TIG) is an advanced biopharmaceutical company focused on developing and commercializing novel therapeutics from its proprietary platforms of allogeneic, or donor-derived, expanded stem cells. Two products from the adipose-derived stem cell technology platform are currently in clinical development. Cx601 is in Phase III for the treatment of complex perianal fistulas in Crohn’s disease patients. Cx611 has completed a Phase I sepsis challenge trial and a Phase I/II trial in rheumatoid arthritis. Effective July 31, 2015, TiGenix acquired Coretherapix, whose lead cellular product, AlloCSC-01, is currently in a Phase II clinical trial in acute myocardial infarction (AMI). In addition, the second product candidate from the cardiac stem cell-based platform acquired from Coretherapix, AlloCSC-02, is being developed in a chronic indication. On July 4, 2016, TiGenix entered into a licensing agreement with Takeda, a large pharmaceutical company active in gastroenterology, under which Takeda acquired the exclusive right to commercialize Cx601 for complex perianal fistulas outside the United States. TiGenix is headquartered in Leuven (Belgium) and has operations in Madrid (Spain). For more information, please visit http://www.tigenix.com.

Forward-looking information

This press release may contain forward-looking statements and estimates with respect to the anticipated future performance of TiGenix and the market in which it operates. Certain of these statements, forecasts and estimates can be recognised by the use of words such as, without limitation, “believes”, “anticipates”, “expects”, “intends”, “plans”, “seeks”, “estimates”, “may”, “will” and “continue” and similar expressions. They include all matters that are not historical facts. Such statements, forecasts and estimates are based on various assumptions and assessments of known and unknown risks, uncertainties and other factors, which were deemed reasonable when made but may or may not prove to be correct. Actual events are difficult to predict and may depend upon factors that are beyond the Company’s control. Therefore, actual results, the financial condition, performance or achievements of TiGenix, or industry results, may turn out to be materially different from any future results, performance or achievements expressed or implied by such statements, forecasts and estimates. Given these uncertainties, no representations are made as to the accuracy or fairness of such forward-looking statements, forecasts and estimates. Furthermore, forward-looking statements, forecasts and estimates only speak as of the date of the publication of this press release. TiGenix disclaims any obligation to update any such forward-looking statement, forecast or estimates to reflect any change in the Company’s expectations with regard thereto, or any change in events, conditions or circumstances on which any such statement, forecast or estimate is based, except to the extent required by Belgian law.

SHS announces investment partnership with 3D printed medical device company EIT

Posted On September 23, 2016 By OrthoSpineNews In Financial /

September 22, 2016

German 3D printed orthopedic device manufacturer Emerging Implant Technologies (EIT) has just announced that it has received a significant investment from German private equity company SHS mbH. With the new funds, EIT, a pioneer in making 3D printed medical orthopedic devices, will seek to both expand its international presence, notably within the United States, and continue developing its range of innovative products.

Emerging Implant Technologies was founded in 2014 in Tuttlingen, Germany and has established itself as a reliable manufacturer of 3D printed orthopedic medical devices and implants. Using Selective Laser Melting (SLM) technologies, the young company has developed its own EIT Cellular Titanium(R) structures, which have properties such as 80% porosity and diamond pores the size of roughly 650 μm, which in mimicking trabecular bone structure, help to promote natural bone growth.

The company also offers patient specific implants, and a complete spinal fusion cage portfolio, including a Cervical Cage implant, PLIF cage, TLIF cage, and a soon to be released ALIF cage. Guntmar Eisen, founder and CEO of EIT, explains: “Our EIT Cellular Titanium implants provide the answer to current challenges in implant design and choice of materials as well the extreme cost pressure in medical technology. The additive manufacturing technology allows us to tackle existing problems with new solutions. Thus we can improve the benefits for patients without increasing costs, which is a clear competitive advantage.”

EIT’s new investment, which comes from SHS’s fourth fund generation (itself worth a total of 125 million euro), will facilitate the expansion of the 3D printed medical device manufacturer into other countries such as the United States and will allow them to develop more innovative and useful additively manufactured implants for the medical industry.

As Dr. Bernhard Schirmers, Managing Partner at SHS Gesellschaftfür Beteiligungsmanagement, explains, “EIT’s 3D-printed spine implants have already proven their superior functionality many times in practical applications, thus promoting EIT’s growth. EIT Emerging Implant Technologies’ management team is experienced and successful in the field of spine surgery. As a medical technology investor, we look forward to supporting them on their path to increased growth.”

SHS, which invests primarily in medical technology and life-science companies, is planning on making more investments and even acquisitions within the industry in the coming months. According to a press release, these additional investments will be for companies in Germany, Austria, and Switzerland. SHS’s investments are usually focused on “expansion financing, changes in shareholder structures, and successor situations.”

Posted in 3D Printer Company

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