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 completion of enrollment in its second pivotal Phase III trial evaluating CINGAL^®, its novel HA-corticosteroid combination viscosupplement¹ for the treatment of symptoms associated with osteoarthritis (“OA”) of the knee.

CINGAL is poised to be the first and only viscosupplement in the U.S. market to combine triamcinolone hexacetonide, a well-established, FDA-approved steroid utilized to treat inflammation, with Anika’s proprietary cross-linked, non-animal-derived hyaluronic acid, which is the active ingredient in the company’s global market-leading viscosupplements, ORTHOVISC^® and MONOVISC^®. The second pivotal Phase III trial, which will evaluate 576 patients with mild to moderate knee osteoarthritis, is designed to evaluate the safety of CINGAL as well as its effectiveness in improving pain, function, and quality of life measures over a 26-week period, in comparison to MONOVISC and triamcinolone hexacetonide.

“We’re proud to have rapidly achieved this major milestone on the path to seeking U.S. regulatory approval for CINGAL, which is key to driving future growth for the company and adding to our market leadership position in orthobiologics,” said Charles H. Sherwood, Ph.D., Chief Executive Officer of Anika Therapeutics. “With its novel and proprietary combination of two proven treatments, and its demonstrated ability to provide immediate and long-lasting pain relief, CINGAL will bridge a significant gap in the non-invasive, non-opioid osteoarthritis treatment landscape, which has not seen a major innovation for over a decade.”

Anika recently published results from its initial Phase III trial, which formed the basis for CINGAL’s Health Canada and CE Mark approvals in November 2015 and March 2016, respectively. The trial, which compared the safety and efficacy of CINGAL to MONOVISC and placebo (saline), showed that CINGAL provided superior 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 placebo (saline).

Anika expects to complete the CINGAL second pivotal Phase III trial in the first half of 2018 and anticipates FDA approval the following year.

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 first sentences of the second, third, and fifth paragraphs 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 driving the Company’s future growth and the Company’s expectations regarding completion of the second pivotal 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 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.

IRVINE, Calif.–(BUSINESS WIRE)–Irvine-based Biogennix, an osteobiologics company which develops, manufactures, and distributes proprietary bone graft substitutes used for bone fusion procedures, announced today that it is expanding its distribution efforts for its novel bone graft substitutes, Morpheus™ and osteoSPAN™ to full national distribution.

The products are resorbable, moldable, osteoconductive scaffolds ideally suited for bone regeneration and optimal handling by surgeons.

News of Biogennix’s decision to expand its marketing of the products to a national level follows on the heels of last month’s announcement that Morpheus and osteoSPAN have now been used in more than 6000 patients.

“Our regionally focused efforts to market Morpheus and osteoSPAN bone graft products have exceeded expectations thus far,” said Scott Bauccio, Biogennix’s Vice President of Sales and Business Development. “We believe these products are fast becoming the new standard of effectiveness and ease of use when it comes to bone graft substitutes. They have been so well received by the clinician and patient communities that it makes sense that we expand our distribution on a nationwide level.”

Bauccio added that he and other key members of Biogennix’s executive team are attending the North American Spine Society (NASS) Meeting in Orlando this week, meeting with potential spine sales team members and reps as part of the growth phase.

Biogennix is a leading developer of osteobiologic products specifically designed for spine fusion and bone trauma. The company is led by a team of scientists and industry veterans committed to delivering unique products for bone regeneration. Biogennix designs, manufactures and distributes all of its products from its Irvine facilities.

Biogennix™ is a fully-integrated osteobiologic company headquartered in Irvine which develops, manufactures, and distributes proprietary bone graft substitutes used in bone fusion procedures. Learn more at biogennix.com.

SAN ANTONIO, Texas–(BUSINESS WIRE)–Tissue Regenix Group plc (AIM:TRX) (‘Tissue Regenix’ or ‘The Group’) the UK based regenerative medical devices company announces subsidiary CellRight Technologies (‘CellRight’) will be participating in The North American Spine Society annual meeting – NASS 2017, being held in Orlando, Florida, October 25-28 2017.

NASS is the largest spine exhibition in the world where spine care professionals from around the globe will share the latest information on new technologies, innovative techniques and procedures, and best practice.

NASS is the first conference that the Group have attended since completing the acquisition of CellRight Technologies in August. The Group will be exhibiting at booth #1343 promoting its range of products including Matrix OI® stem cell containment products, MatrixCellect 100 DBM putty, ConCelltrate Inductive Carrier Matrix and Matrix OI Cortical Fibers.

CellRight is focused on innovative product development expanding the potential of regenerative solutions in the osteobiologics field, offering surgeons and patients a biologic product portfolio.

With products that are 100% allograft bone, the innovative platform technology preserves the native Bone Morphogenic Proteins (BMPs) and growth-factors to verify osteoinductivity needed for bone regeneration, resulting in best-in-class products and ensuring superior clinical outcomes. CellRight verifies osteoinductivity for every lot post sterilization and these osteogenic bioengineered implants address indications in the spine, trauma, TJA and sports medicine fields.

The CellRight technology complements dCELL® Technology, Tissue Regenix’ patented decellularization process for soft tissues. In due course, soft tissue products for use in various orthopedics applications, with an initial focus on ligament reconstruction, will also be processed at the state-of-the-art CellRight tissue bank facility based in San Antonio, Texas.

Jesus Hernandez, CEO CellRight Technologies commented: “We are delighted to be attending NASS as part of the larger Tissue Regenix Group. This conference offers a unique opportunity to showcase our portfolio of innovative spinal products and discuss the future potential of the combined CellRight and dCELL® platforms with some of the best healthcare specialists in the world.”

###

About Tissue Regenix

Tissue Regenix is a leading medical devices company in the field of regenerative medicine. Tissue Regenix was formed in 2006 when it was spun-out from the University of Leeds, UK. The company’s patented decellularisation (‘dCELL^®‘) technology removes DNA and other cellular material from animal and human soft tissue leaving an acellular tissue scaffold which is not rejected by the patient’s body and can then be used to repair diseased or worn out body parts. Current applications address many critical clinical needs such as sports medicine, heart valve replacement and wound care.

In November 2012 Tissue Regenix Group plc set up a subsidiary company in the United States – ‘Tissue Regenix Wound Care Inc.’, January 2016 saw the establishment of joint venture GBM-V, a multi- tissue bank based in Rostock, Germany.

In August 2017 Tissue Regenix acquired CellRight Technologies^®, a biotech company that specializes in regenerative medicine and is dedicated to the development of innovative osteoinductive and wound care scaffolds that enhance healing opportunities of defects created by trauma and disease.