Anika Therapeutics Reports Hyaluronic Acid Enhanced Nerve Regeneration in Preclinical Study; Study Results Published in Journal of Microsurgery.

WOBURN, Mass.--(BUSINESS WIRE)--Dec 16, 1998--Adding important data to the growing area of nerve regeneration research, Anika Therapeutics, Inc. (Nasdaq:ANIK) today said results of a preclinical animal study published in the December issue of the Journal of Microsurgery reported that Anika Therapeutics' highly purified hyaluronic acid (HA) formulation enhanced peripheral nerve regeneration in vivo.

Previous studies have shown that a large gap in the peripheral nerve will not undergo effective regeneration unless a grafting conduit is used to bridge the defect. In this preclinical study, led by Kai-Kai Wang, M.D. and Brooke Seckel, M.D. of the Department of Plastic Surgery at the Lahey Clinic, Burlington, MA, researchers evaluated the use of HA injected into a transected gap in the sciatic nerve of rats.

The study results demonstrated a statistically significant increase in the peripheral nerve conduction velocities in the HA groups as compared with control group as measured by electromyography (EMG). In addition, histological analysis indicated that Anika's highly purified HA formulation showed a significant increase in sciatic midcable myelinated axon counts. Finally, the HA groups also showed increased nerve branching, further supporting a possible clinical benefit of using HA in enhancing peripheral regeneration.

It is believed that, like wound healing, peripheral nerve regeneration represents a biological process that first requires the deposition of an extracellular matrix that serves to support and guide the ingrowth of neural cells. The authors indicate that HA may be associated with certain aspects of the remodeling pathway necessary for cell and axon transport.

"Because HA has been demonstrated to influence cell proliferation, it may have a useful role in cellular ingrowth during peripheral nerve regeneration," said Dr. Seckel, chairman of Lahey's Department of Plastic Surgery. "These are exciting findings that may eventually lead to important therapeutic applications, and we look forward to conducting more research in this promising area."

Noted J. Melville Engle, president and chief executive officer of Anika Therapeutics, "The results from this study indicate an important potential therapeutic use for Anika's proprietary HA formulation." He added that Anika also has an agreement with the Lahey Clinic to study HA in a spinal cord regeneration preclinical model.

"As has been demonstrated with OSSIGEL(tm), HA can be a valuable delivery matrix for growth factors in the healing of fractures," Engle continued, referring to the product which Anika is producing for its partner, Orquest, Inc. of Mountain View, CA. "While this preclinical model in nerve regeneration assessed HA alone, it demonstrated promise for other potential uses of HA in future research."

HA is a naturally occurring biocompatible polymer found throughout the body. It is involved in a number of physiological functions such as the protection and lubrication of tissues, the maintenance and structural integrity of tissues and the transport of molecules to and within cells.

Anika Therapeutics, Inc. (www.anikatherapeutics.com) develops, manufactures and commercializes therapeutics products and devices intended to promote the protection and healing of bone, cartilage and soft tissue. These products are based on hyaluronic acid (HA), a naturally occurring biocompatible polymer found throughout the body. Anika's currently marketed products consist of ORTHOVISC(R) for the treatment of osteoarthritis in humans and HYVISC(R) for the treatment for the treatment of equine osteoarthritis. Anika also manufactures AMVISC(R) and AMVISC Plus(R), highly viscous HA products used as viscoelastic supplements in ophthalmic surgery, for Bausch & Lomb Surgical. Therapies currently under development currently include INCERT(R), an HA product designed to prevent post-surgical adhesions, and HA oligosaccharides for the treatment of cancer. Anika is also collaborating with Orquest, Inc., to manufacture OSSIGEL, an injectable formulation of basic fibroblast growth factor combined with HA designed to accelerate the healing of bone fractures.

The statements made in this press release which are not historical facts are forward-looking statements within the meaning of Section 27A of the Securities Exchange Act of 1933 and Section 21E of the Securities Exchange Act of 1934. The Company's actual results could differ materially from those set forth in the forward-looking statements as a result of a number of factors. In particular, the Company will need to successfully design and complete additional studies to demonstrate the effectiveness of HA in nerve regeneration. There can be no assurance that such a trial or trials can be completed in a timely manner or at all or, if completed, that the results of such a trial will produce data supporting the effectiveness of HA. Certain other factors that might cause the Company's actual results to differ materially from those set forth in the forward-looking statements include those factors set forth under the heading "Risk Factors" in the Company's 10-KSB filed with the Securities and Exchange Commission on March 31, 1998 as well as those listed in the Company's other SEC filings.