American Academy of Orthopaedic Surgeons announces the launch of its Shoulder and Elbow Registry

ROSEMONT, IllOct. 24, 2018 /PRNewswire/ — The American Academy of Orthopaedic Surgeons (AAOS) announced the launch of its Shoulder and Elbow Registry (SER) to begin collecting data on total shoulder and elbow procedures in the United States. At launch, the SER will collect total shoulder arthroplasty procedures data. In 2019, the registry also will have the capability to capture rotator cuff repair and total elbow arthroplasty procedures data.

“Registries are tools to help the medical profession collect data, report, and benchmark to define patient-centered quality care to identify potential procedural or implant problems before it becomes a widespread public health issue. Other national joint replacement registries such as the Swedish Hip Arthroplasty Register have proven that monitoring survivorship can reduce revision rates. That translates into reducing direct medical costs and, more importantly, improving patient care and quality of life,” says AAOS President David A. Halsey, MD, a Fellow of the American Academy of Orthopaedic Surgeons.

The AAOS is the world’s largest medical association of musculoskeletal specialists. The SER will be the second in a series of anatomical registries in development as part of the AAOS’ Registry Program to establish survivorship curves, track revisions, and improve quality of care for all patients. The American Joint Replacement Registry (AJRR)—the Academy’s hip and knee replacement registry—is the cornerstone of the AAOS’s Registry Program, and the world’s largest national registry of hip and knee joint replacement data by annual procedural count, with more than 1.4 million procedures contained within its database.

“In addition to reducing the overall public cost, joint registries demonstrate up to a 50 percent reduction in revision rates after registry initiation and identification of best practices,” says Gerald R. Williams Jr., MD, chair of the AAOS’ SER Steering Committee and Fellow of the American Academy of Orthopaedic Surgeons. “There are more than 750,000 total shoulder arthroplasty, rotator cuff repair, and total elbow arthroplasty surgeries performed in the United Stateseach year. An evidence-based registry, like the Shoulder and Elbow Registry, is a cost-effective way to benchmark risk-adjusted data, and provide greater context to patient outcomes comparisons. Identifying improvement needs can potentially mitigate surgical revisions which could lead to millions of dollars in stakeholder savings annually.”

The SER was developed in conjunction with representatives from the American Shoulder and Elbow Surgeons (ASES), the American Orthopaedic Society for Sports Medicine, and the Arthroscopy Association of North America.

“In 1917, American shoulder surgery pioneer EA Codman challenged that patients should be followed long enough to determine if treatments proved successful. More than 100 years later, the AAOS and the ASES are taking a huge step toward that goal,” says Grant E. Garrigues, MD, a Fellow of the American Academy of Orthopaedic Surgeons. “Every ASES member must take up this charge and truly follow our shoulder patients’ outcomes, pool this data with other surgeons, and determine the optimal treatments for our patients. This registry is a powerful tool to make this possible. This type of data registry is the key to improving patient outcomes and defining best practices.”

About the AAOS
With more than 38,000 members, the American Academy of Orthopaedic Surgeons (AAOS) is the world’s largest medical association of musculoskeletal specialists. The AAOS provides educational programs for orthopaedic surgeons and allied health professionals, champions and advances the highest quality musculoskeletal care for patients, and is the authoritative source of information on bone and joint conditions, treatments and related issues.

More information about the AAOS  
More information about the AAOS Shoulder and Elbow Registry  
Follow the AAOS on FacebookTwitter and Instagram

SOURCE American Academy of Orthopaedic Surgeons

Related Links

http://www.aaos.org

CartiHeal Performs the 100th Agili-C™ Implant Procedure in Italy in the Company’s IDE Multinational Pivotal Study

KFAR SABA, Israel and MILANOct. 25, 2018 /PRNewswire/ — CartiHeal, developer of the proprietary Agili-C implant for the treatment of joint surface lesions, and the Principal Investigator Professor Elizaveta Kon, MD, PhD of Humanitas Orthopedic Center of Milan, announced today the successful enrollment and surgery  of  the 100th patient in the Agili-C IDE pivotal study.

“I’m excited to operate on the 100th patient in this important IDE study. The patient I enrolled and operated on today is a 47-year-old female, with a 3.6cm2 osteochondral defect in the center of the trochlea” said Prof. Kon. “The patient was randomized to the Agilli-C arm and treated with a single implant. I’m very pleased that the patient was randomized to the implant group, as I have very positive experience using this implant for similar indications. If everything goes as planned, I expect fast recovery and significant pain relief. This was my 8th patient in the study and I’m planning to enroll more patients shortly”, she added.

“I’ve been involved in CartiHeal’s previous clinical trials, and operated to date on over 40 patients with the Agili-C. Based on the positive clinical outcomes from the previous studies, I have strong confidence that this implant will be a game changer in the field of cartilage repair” concluded Prof. Kon.

Nir Altschuler, CartiHeal’s founder & CEO said: “Prof. Kon is a great surgeon and one of the first in the world to use our Agili-C implant. Her first patients were operated on over 4 years ago. We are pleased and impressed with her enrollment rate, and look forward to continuing our collaboration.

We’d like to thank all our Investigators and Study Coordinators for enrolling 100 patients in the first year of the study.”

The IDE study that was initiated a year ago is currently ongoing in the US, EU and Israel, with the purpose of an FDA PMA application. The trial’s objective is to demonstrate the superiority of the Agili-C implant over surgical standard of care (microfracture and debridement) for the treatment of cartilage or osteochondral defects, in both arthritic knees and knees without degenerative changes.

For more information about the study please refer to www.cartiheal.com

CartiHeal’s cell-free, off-the-shelf implant is CE marked for use in cartilage and osteochondral defects. Agili-C has been implanted in over 400 patients with cartilage lesions in the knee, ankle and great toe in a series of trials conducted at leading centers in Europe and Israel. In these trials, the implant was used to treat a broad spectrum of cartilage lesions, from single focal lesions to multiple and large defects in patients suffering from osteoarthritis.

About CartiHeal

CartiHeal, a privately-held medical device company with headquarters in Israel, develops proprietary implants for the treatment of cartilage and osteochondral defects in traumatic and osteoarthritic joints.

In the United States, the Agili-C implant is not available for sale – it is an investigational device limited for use in the IDE study only.

Contact:           
info@cartiheal.com 
www.cartiheal.com

SOURCE CartiHeal

Related Links

http://www.cartiheal.com

Samumed Phase 2b Trial in Knee Osteoarthritis Meets Primary Endpoints

SAN DIEGO, Oct. 24, 2018 (GLOBE NEWSWIRE) — Samumed announced today top-line data from its phase 2b trial of SM04690 in knee osteoarthritis (OA). Results showed that treatment with a single intra-articular injection of SM04690 demonstrated significant improvements in pain, function and patient global scores in two separate doses. Further details can be found here.

Samumed’s phase 2b trial was a 700-patient, 24-week, multi-center, randomized, double-blind, placebo-controlled study of four concentrations of SM04690, a Wnt pathway inhibitor, injected once intra-articularly into the target knee joint of subjects with moderately to severely symptomatic knee OA. Details of the study can be found here.

“The safety profile, the improvements in signs and symptoms, and the disease-modifying benefits of SM04690 that we have observed in this phase 2b as well as earlier studies, are quite promising,” said Osman Kibar, CEO of Samumed. “We look forward to working with the FDA to take SM04690 into phase 3 pivotal trials, targeting a start date in early 2019.”

About SM04690 and Osteoarthritis
SM04690 is a small molecule inhibitor of the Wnt pathway administered as an intra-articular injection and is being developed as a potential disease-modifying drug for osteoarthritis (DMOAD). SM04690’s mechanism of action exhibits three separate effects on joint health – generation of cartilage, slowing down of cartilage breakdown, and reduction of inflammation. There are currently no approved disease-modifying treatments for osteoarthritis. Additional information on Samumed’s SM04690 osteoarthritis program can be found here: https://www.samumed.com/pipeline/detail.aspx?id=20

About Samumed 
Samumed’s small-molecule drug platform is harnessing the innate restorative power of the Wnt pathway to reverse the course of severe and prevalent diseases. Learn more about Samumed’s potential regenerative drug candidates and broad clinical pipeline at https://www.samumed.com/pipeline/default.aspx

Corporate Contact:
Erich Horsley
Samumed, LLC
erich@samumed.com
858-365-0200

Investor Contact:
Ashley Robinson
LifeSci Advisors
arr@lifesciadvisors.com
617-535-7742

Media Contact:
Josephine Belluardo, Ph.D.
LifeSci Public Relations
jo@lifescipublicrelations.com
646-751-4361

Susan M. Stalnecker Named to Bioventus Board of Managers

October 25, 2018

DURHAM, N.C.–(BUSINESS WIRE)–Bioventus, a global leader in orthobiologic solutions, today announced the appointment of Susan M. Stalnecker, former Vice President and Treasurer, E.I. du Pont de Nemours and Company, to the company’s Board of Managers, replacing Michael Minogue.

“Susan is joining the Bioventus Board at an exciting time as we accelerate the growth of our osteoarthritis business, expand our surgical orthobiologics business and continue to launch our products in new international markets like Brazil,” said Tony Bihl, CEO of Bioventus. “Her global financial background, experience leading audit and finance committees and leadership roles on both public company and nonprofit boards will provide us with fresh perspectives and insights to help drive our strategy to be a global leader in orthobiologics.”

“The orthobiologic space intrigues me and I believe I can help the team at Bioventus achieve their goals of bringing more solutions to market to help patients heal and return to active lifestyles,” said Stalnecker. “Clinicians and spine surgeons around the world are noticing this company and its innovations, and I am eager to guide Bioventus as it continues to grow into these markets.”

Stalnecker served as Vice President of E. I. du Pont de Nemours and Company until she retired in 2016. During her nearly 40-year career at DuPont she served in several senior leadership roles including Vice President, Treasurer & M&A Vice President, Risk Management; Vice President-Government and Consumer Markets; and, Vice President Productivity & Shared Services.

Stalnecker served on the Board of trustees of Duke University from 2003 to 2015, and as Vice Chair from 2003-2005. She currently serves on the Board of Directors of Leidos Holdings, Inc., Board of Trustees, Optimum Fund Trust and the Board of Trustees, Duke Health System. In addition, she was a Board Director of PPL Corporation. She is also a Senior Adviser, Boston Consulting Group.

She received a bachelor’s degree from Duke University and an MBA from the Wharton School of Graduate Business at the University of Pennsylvania.

About Bioventus

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

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

Contacts

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

Camber Spine Announces Hitting $1M Milestone With SPIRA™-C In Less Than 6 Months

Aurora Spine Announces European Patent Related To ZIP Minimally Invasive Spinal Implant

CARLSBAD, Calif., Oct. 25, 2018 (GLOBE NEWSWIRE) — Aurora Spine Corporation (TSXV:ASG) (“Aurora Spine” or the “Company”) announced today the grant by the European Patent Office (the “EPO”) of Aurora’s first European patent related to the ZIP®, minimally invasive spinal implant. The patent is titled “Dynamic and Non-Dynamic Interspinous Fusion Implant and Bone Growth Stimulation System”, and covers Aurora’s family of ZIP® interspinous devices, including its ZIP Ultra®, ZIP 51™, ZIP LP™ and Dyna-ZIP™ among others.  The EPO has reported that no oppositions have been filed against the European patent.

“The recent European ZIP® Interspinous patent allowance is another milestone in Aurora Spine’s history. This newly issued patent features our patented ONE-STEP™ locking mechanism that eliminates the use of a set screw in Aurora’s Screwless Procedure™ surgeries,” said Laszlo Garamszegi, Chief Technology Officer of Aurora Spine and Co-Inventor of the ZIP. “The ZIP technology provides Aurora Spine with opportunities to market, license and develop its products and screwless, minimally invasive implant technology further. We are very proud of the progress that we have made over the past couple of years in spinal surgery and the remarkable value that Aurora Spine`s intellectual property has added to our company`s growth.”

“Aurora is changing spine surgery, and we are thrilled that our newest patent has been issued by the EPO. This patent further validates the modern advancements of our Screwless technology and it maintains our commitment to introduce advanced minimally invasive spine surgery technologies,” said Trent Northcutt, President and CEO of Aurora Spine.

This is Aurora Spine’s first European patent. Aurora Spine has several U.S. and international patent applications pending directed to the ZIP system and its future technologies.

About Aurora Spine

Aurora Spine is an early stage company focused on bringing new solutions to the spinal implant market through a series of screwless, innovative, minimally invasive, regenerative spinal implant technologies.  Aurora Spine continues to position itself at the forefront of spinal surgery procedures, focusing on minimally invasive spine surgery technologies. Aurora Spine is changing spine surgery by focusing on disruptive technologies following the Company’s commitment to – Simplifying the Complex.

Forward-Looking Statements

This news release contains forward-looking information that involves substantial known and unknown risks and uncertainties, most of which are beyond the control of Aurora Spine, including, without limitation, those listed under “Risk Factors” and “Cautionary Statement Regarding Forward-Looking Information” in Aurora Spine’s final prospectus (collectively, “forward-looking information”). Forward-looking information in this news release includes information concerning the Offering and the proposed use of proceeds of the Offering. Aurora Spine cautions investors of Aurora Spine’s securities about important factors that could cause Aurora Spine’s actual results to differ materially from those projected in any forward-looking statements included in this news release. Any statements that express, or involve discussions as to, expectations, beliefs, plans, objectives, assumptions or future events or performance are not historical facts and may be forward-looking and may involve estimates, assumptions and uncertainties which could cause actual results or outcomes to differ unilaterally from those expressed in such forward-looking statements. No assurance can be given that the expectations set out herein will prove to be correct and, accordingly, prospective investors should not place undue reliance on these forward looking statements. These statements speak only as of the date of this press release and Aurora Spine does not assume any obligation to update or revise them to reflect new events or circumstances.

For more information, please contact:

Aurora Spine Corporation

Trent Northcutt
President and Chief Executive Officer
(760) 424-2004

Sarina Mason
Chief Financial Officer
(760) 424-2004

www.aurora-spine.com

SpinalCyte Announces Positive 12 Month Pain Data From Phase 1/Phase 2 Clinical Trial for Degenerative Disc Disease

October 25, 2018

HOUSTON–(BUSINESS WIRE)–SpinalCyte, LLC, a Texas-based regenerative medicine company focused on regrowth of the spinal disc nucleus using human dermal fibroblasts (HDFs), today announced 12-month endpoint data from its Phase 1/Phase 2 clinical trial for treatment of degenerative disc disease (DDD). The analysis showed that patients who received intradiscal injections of the HDF product CybroCell™ had sustained improvement in pain relief and increased back mobility after 12 months. The sustained pain relief suggests that there is a regenerative process stimulated by its cell-based therapy, CybroCell. CybroCell is the first off-the-shelf allogeneic HDF product for treatment of degenerative disc disease.

The landmark Phase 1/Phase 2 clinical trial included 24 patients with chronic lower back pain caused by DDD. The patients’ pain levels were measured using the Oswestry Disability Index (ODI) and the Visual Analogue Scale (VAS) at 6 and 12-months post-treatment. At the 12-month endpoint, more than 90% of the treatment group had over a 10-point reduction in ODI and 100% had improvement in VAS. On average, treatment group patients showed a 61% improvement over baseline ODI scores, compared to 29% improvement in the placebo group. Patients received intradiscal injections in one to three spinal discs and were randomly assigned to treatment groups which received: a saline injection, an injection of 10 million HDFs or an injection of 10 million HDFs in combination with platelet-rich plasma (PRP).

Previous MRI data from the 6-month endpoint demonstrated superior outcomes in the treatment versus the control group. Of the treatment group, 83% demonstrated increased disc height or no change in one or more discs compared to 66% of control patients. More than half 52% of CybroCell-treated discs showed either increased disc height or no change versus only 38% of control discs. Preclinical animal studies have demonstrated that an intradiscal injection of CybroCell resulted in significant increase in regeneration, disc height, gene expression of structural genes such as collagen type I and collagen type II, and the contents of structural proteins such as proteoglycan, which in turn regenerate the disc nucleus.

“We are encouraged by the significant pain reduction of the CybroCell patients over the control patients,” said SpinalCyte Chief Scientific Officer, Thomas Ichim, Ph.D. “CybroCell has demonstrated clinically relevant outcomes in the area of pain reduction for those patients who received treatment injections. The data suggests CybroCell possesses tangible pain reduction benefits for people suffering from degenerative disc disease, a chronic condition for which previous treatments have not demonstrated a physical improvement in the degenerated disc.”

“We are excited about the sustained pain reduction we witnessed in the treatment arm patients from 6 months to 12 months,” said Pete O’Heeron, Chief Executive Officer, SpinalCyte. “This study provides evidence of long-term reduction in pain and quality of life improvement for treated patients. This will ultimately lead to a reduction or elimination in need for opioids for chronic back pain patients and address the critical opioid epidemic in the U.S.”

SpinalCyte’s Phase 1/Phase 2 clinical trial is the first allogeneic use of fibroblasts outside of skin conditions. Considering how relatively easy it is to collect large numbers of fibroblasts which would otherwise be disposed of, researchers believe this trial will advance the clinical translation of fibroblasts into other areas of regenerative medicine.

About SpinalCyte

Based in Houston, Texas, SpinalCyte, LLC is a regenerative medicine company developing an innovative solution for spinal disc regeneration using human dermal fibroblasts. Currently, SpinalCyte holds 33 U.S. and international issued patents and has filed for an additional 43 patents pending. Funded entirely by angel investors, SpinalCyte represents the next generation of medical advancement in cell therapy. Visit www.spinalcyte.com.

Contacts

Russo Partners LLC
David Schull, 858-717-2310
david.schull@russopartnersllc.com
or
Ned Berkowitz, 646-942-5629
ned.berkowitz@russopartnersllc.com
or
SpinalCyte, LLC
info@spinalcyte.com

Life Spine Announces Tremendous Profit and Revenue Growth in the Third Quarter of 2018

October 23, 2018

HUNTLEY, Ill.–(BUSINESS WIRE)–Life Spine, a medical device company that designs, develops, manufactures and markets products for the surgical treatment of spinal disorders, announced today that the company recognized an EBITDA growth rate of 124% in the third quarter of 2018 over the third quarter of 2017. This was driven by a sales growth of 47% in the same period led by significant growth to their micro-invasive portfolio.

“Our accelerated financial growth in 2018 is a direct result of our dedication to being the most innovative company in spine. We have remained focused on launching products that are designed with the intention of reducing surgical procedure time, reducing operating costs, and providing better patient outcomes. We are excited that so far 2018 has exceeded our growth expectations and looking forward to 2019 we know we will see continued success through both our existing portfolio and the groundbreaking product launches slated for the coming months,” said Omar Faruqi, Chief Financial Officer for Life Spine.

About Life Spine

Life Spine is dedicated to improving the quality of life for spinal patients by increasing procedural efficiency and efficacy through innovative design, uncompromising quality standards, and the most technologically advanced manufacturing platforms. Life Spine, which is privately held, is based in Huntley, Illinois. For more information, please visit: http://www.lifespine.com.

Contacts

Life Spine
Mr. Omar Faruqi
Chief Financial Officer
ofaruqi@lifespine.com
847-884-6117

Anika Reports Third Quarter 2018 Financial Results

October 24, 2018

BEDFORD, Mass.–(BUSINESS WIRE)–Anika Therapeutics, Inc. (NASDAQ: ANIK), a global, integrated orthopedic and regenerative medicines company specializing in therapeutics based on its proprietary hyaluronic acid (“HA”) technology, today reported financial results for the third quarter ended September 30, 2018, and provided an update on its business progress in the period.

“Anika delivered solid financial results in the third quarter, while continuing to take important steps to accelerate revenue growth in 2019 and beyond,” said Joseph Darling, President and Chief Executive Officer of Anika Therapeutics. “We are encouraged by the continued advances we are making across our deep pipeline and diverse commercial portfolio. During the quarter, CINGAL end user demand in Canada and Europe remained strong, and we were pleased to add four new distribution partners to further expand our commercial reach in Europe, Asia and South America. Focused international expansion efforts enabled us to realize a 31% year-over-year increase in international Viscosupplement revenue while we continued to generate strong earnings and cash flow. As we prepare to discuss the pathway for U.S. regulatory approval for CINGAL with the U.S. Food and Drug Administration in the first quarter of 2019, we believe Anika is well-positioned to transform into a global commercial company increasingly capable of generating significant value for our patients and shareholders.”

Third Quarter Financial Results

  • Total revenue for the third quarter of 2018 was $26.8 million, compared to $27.2 million for the third quarter of 2017. The year-over-year decline was due primarily to the impact from the voluntary recall of HYALOFAST, HYALOGRAFT-C, and HYALOMATRIX announced in May 2018.
  • Global Viscosupplement revenue increased 2% year-over-year for the third quarter of 2018, while international Viscosupplement revenue increased 31% during the same period. The increases were primarily due to the growth of CINGAL in international markets, as well as the continued global expansion of Viscosupplement products overall.
  • Total operating expenses for the third quarter of 2018 were $18.2 million, compared to $16.9 million for the third quarter of 2017. The increase in total operating expenses was due primarily to higher production costs and increased personnel and professional costs.
  • Net income for the third quarter of 2018 increased to $7.6 million, or $0.53 per diluted share, compared to $6.9 million, or $0.46 per diluted share, for the third quarter of 2017. The increase in net income was due primarily to the reduction in R&D expenses as a result of the completion of the CINGAL 16-02 study and lower income tax expenses in 2018.

Recent Business Highlights

  • Continued to work with external regulatory and legal experts to seek regulatory approval of CINGAL in the U.S. market. Anika plans to meet with the U.S. Food and Drug Administration (FDA) in the first quarter of 2019 and is developing multiple strategies to enable the company to move forward expeditiously once it has received guidance from the FDA regarding the pathway for CINGAL.
  • Advanced the Company’s product pipeline with the completion of preclinical development activities for its regenerative therapy for rotator cuff repair.
  • Strengthened Anika’s international product distribution network and expanded the Company’s commercial reach with four new distribution partners in Europe, Asia and South America.
  • Continued to evaluate potential partnership opportunities for the Company’s expansive product pipeline as part of the ongoing work on its 5-year strategic plan.
  • Convened an international distributor meeting at the Company’s European headquarters to align key growth objectives and market approach strategies for 2019.
  • Appointed Cheryl Blanchard, Ph.D., and Susan Vogt as new independent members of the Company’s Board of Directors.

Full Year 2018 Revised Corporate Outlook
Based on currently available information, the Company anticipates full year product revenue to be approximately 3% below prior year. The Company continues to expect that it will resume the shipment of products that were the subject of the previously-disclosed voluntary recall by the end of this year. Total operating expenses are now expected to be reduced to the high $80 million range for the full year of 2018 as a result of successful cost control initiatives.

Conference Call Information
Anika’s management will hold a conference call and webcast to discuss its financial results and business highlights today, Wednesday, October 24 at 5:00 pm ET. The conference call can be accessed by dialing 1-855-468-0611 (toll-free domestic) or 1-484-756-4332 (international). A live audio webcast will be available in the Investor Relations section of Anika’s website, www.anikatherapeutics.com. An accompanying slide presentation may also be accessed via the Anika website. A replay of the webcast will be available on Anika’s website approximately two hours after the completion of the event.

About Anika Therapeutics, Inc.
Anika Therapeutics, Inc. (NASDAQ: ANIK) is a global, integrated orthopedic and regenerative 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 tissue 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 second paragraph of this press release and in the Section captioned “Full Year 2018 Corporate Outlook,” 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 expected meeting with the U.S. Food and Drug Administration during the first quarter of 2019, the Company’s full-year 2018 product revenue and operating expense projections, and the Company’s expectations related to shipment of products previously subject to the voluntary recall. 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.

Anika Therapeutics, Inc. and Subsidiaries
Consolidated Statements of Operations
(in thousands, except per share data)
(unaudited)
For the Three Months Ended September 30, For the Nine Months Ended September 30,
2018 2017 2018 2017
Product revenue $ 26,781 $ 27,178 $ 78,581 $ 78,899
Licensing, milestone and contract revenue 6 6 18 5,133
Total revenue 26,787 27,184 78,599 84,032
Operating expenses:
Cost of product revenue 8,282 6,250 24,279 18,648
Research and development 4,232 5,842 14,126 14,521
Selling, general and administrative 5,700 4,823 28,207 14,862
Total operating expenses 18,214 16,915 66,612 48,031
Income from operations 8,573 10,269 11,987 36,001
Interest and other income, net 522 261 907 335
Income before income taxes 9,095 10,530 12,894 36,336
Provision for income taxes 1,496 3,643 1,890 12,587
Net income $ 7,599 $ 6,887 $ 11,004 $ 23,749
Basic net income per share:
Net income $ 0.53 $ 0.47 $ 0.76 $ 1.63
Basic weighted average common shares outstanding 14,237 14,579 14,524 14,572
Diluted net income per share:
Net income $ 0.53 $ 0.46 $ 0.74 $ 1.58
Diluted weighted average common shares outstanding 14,377 15,115 14,820 15,065
Anika Therapeutics, Inc. and Subsidiaries
Consolidated Balance Sheets
(in thousands, except per share data)
(unaudited)
ASSETS September 30,
2018
December 31,
2017
Current assets:
Cash, cash equivalents and investments $ 149,011 $ 157,256
Accounts receivable, net 20,771 23,825
Inventories, net 23,828 22,035
Prepaid expenses and other current assets 1,981 3,211
Total current assets 195,591 206,327
Property and equipment, net 55,041 56,183

Other long-term assets

1,109 1,254
Intangible assets, net 9,564 10,635
Goodwill 7,959 8,218
Total assets $ 269,264 $ 282,617
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable $ 2,462 $ 6,747
Accrued expenses and other current liabilities 6,843 6,326
Total current liabilities 9,305 13,073
Other long-term liabilities 574 660
Deferred tax liability 4,120 5,393
Commitments and contingencies
Stockholders’ equity:
Preferred stock, $0.01 par value
Common stock, $0.01 par value 142 147
Additional paid-in-capital 49,836 68,617
Accumulated other comprehensive loss (5,228 ) (4,784 )
Retained earnings 210,515 199,511
Total stockholders’ equity 255,265 263,491
Total liabilities and stockholders’ equity $ 269,264 $ 282,617
Anika Therapeutics, Inc. and Subsidiaries
Supplemental Financial Data

Revenue by Product Line and Product Gross Margin
(in thousands, except percentages)
(unaudited)

For the Three Months Ended September 30, For the Nine Months Ended September 30,
Product Line: 2018 % 2017 % 2018 % 2017 %
Orthobiologics $ 24,097 90 % $ 23,990 88 % $ 69,778 88 % $ 68,686 87 %
Surgical 1,191 4 % 1,765 7 % 3,700 5 % 4,395 6 %
Dermal 80 1 % 358 1 % 163 1 % 1,235 2 %
Other 1,413 5 % 1,065 4 % 4,940 6 % 4,583 5 %
Product Revenue $ 26,781 100 % $ 27,178 100 % $ 78,581 100 % $ 78,899 100 %
Product Gross Profit $ 18,499 $ 20,928 $ 54,302 $ 60,251
Product Gross Margin 69% 77% 69% 76%

Product Revenue by Geographic Region
(in thousands, except percentages)
(unaudited)

For the Three Months Ended September 30, For the Nine Months Ended September 30,
2018 % 2017 % 2018 % 2017 %
Geographic Region:
United States $ 21,695 81 % $ 22,227 82 % $ 63,377 81 % $ 63,507 81 %
Europe 3,132 12 % 2,832 10 % 9,021 11 % 9,743 12 %
Other 1,954 7 % 2,119 8 % 6,183 8 % 5,649 7 %
Product Revenue $ 26,781 100 % $ 27,178 100 % $ 78,581 100 % $ 78,899 100 %

Contacts

Anika Therapeutics, Inc.
Joseph Darling, 781-457-9000
President & CEO
or
Sylvia Cheung, 781-457-9000
CFO

Susan Vogt Appointed to Board of Directors of Anika Therapeutics

October 24, 2018

BEDFORD, Mass.–(BUSINESS WIRE)–Anika Therapeutics, Inc. (NASDAQ: ANIK) (“Anika” or the “Company”), a global, integrated orthopedic and regenerative medicines company specializing in therapeutics based on its proprietary hyaluronic acid (“HA”) technology, announced that, effective immediately, Anika’s Board of Directors has appointed Susan Vogt as an independent director.

Ms. Vogt most recently served as Chief Executive Officer and Director of Aushon Biosystems, a venture-backed company with a novel multiplex immunoassay platform. She previously served as President, CEO, and a Director of SeraCare Life Sciences, a publicly traded life sciences company focused on human diagnostics and therapeutics. From 2001 to 2005, she served as President of the Biopharmaceutical Division of Millipore Corporation (now MilliporeSigma), where she began her career in 1981. She earned a Master of Business Administration with high honors in Finance from Boston University, where she received a Distinguished Alumni Award in 2009, and a Bachelor of Arts degree from Brown University.

The Company also announced that Steven Wheeler, who has served as a director of Anika since 1993 and currently chairs the Board’s Governance and Nominating Committee, has notified the Board of his intention to retire as of February 8, 2019.

“This is another important step in the transition of Anika’s leadership that began with the appointment of Joseph Darling as CEO in March of this year,” said Joseph L. Bower, Chairman of the Board of Directors, “and it demonstrates our continued commitment to strong corporate governance and refreshment of the Board.”

“Sue brings to Anika more than thirty-five years of experience in the global life science research, pharmaceutical, biotech and clinical diagnostics industries, and we are excited she is joining our Board,” said Joseph G. Darling, President and CEO of Anika. “We are confident that Anika will benefit greatly from her input and guidance as we continue to advance our ongoing initiatives and enhance our global commercial reach.”

“Anika has a strong foundation with a deep pipeline and a diverse commercial portfolio, and I am excited to work with the other directors and management team to continue advancing the Company’s important work. I look forward to leveraging my experience as we continue to advance Anika’s clinical programs, deliver important therapeutic options for patients and drive profitable growth to enhance value for Anika shareholders,” Ms. Vogt said.

About Anika Therapeutics, Inc.

Anika Therapeutics, Inc. (NASDAQ: ANIK) is a global, integrated orthopedic and regenerative 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 tissue 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.

Contacts

For Investor Inquiries:
Anika Therapeutics, Inc.
Sylvia Cheung, 781-457-9000
Chief Financial Officer
or
For Media Inquiries:
Pure Communications, Inc.
Sonal Vasudev, 917-523-1418
sonal@w2ogroup.com