A Medical Device Daily

Advanced Cell Technology (ACT; Alameda, California) reported that it has completed its previously disclosed acquisition of all of the outstanding capital stock of Mytogen (Charlestown, Massachusetts). At the end of May, the company reported that it had entered into a letter of intent to acquire Mytogen and its Myoblast program for the treatment of heart failure (Medical Device Daily, June 1, 2007).

ACT issued a total of about 8.2 million restricted shares of common stock, valued at $5 million, and assumed certain Mytogen liabilities that totaled about $1 million. Mytogen shareholders also received a warrant to purchase an additional 1.5 million shares of restricted common stock at 75 cents per share subject to the achievement of certain milestones.

Mytogen’s stem cell therapy involves transplantation of expanded autologous myoblasts (adult progenitor stem cells) derived from a small biopsy of skeletal muscle from a patient’s leg. The technology is designed to allow for the expansion of myoblasts into hundreds of millions of cells over a period of two to three weeks. The resulting myoblasts are then transplanted back into the patient’s scarred heart tissue through the use of a catheter-based procedure. The Myoblast program has successfully completed Phase I human clinical trials using the myoblast platform, utilizing the therapy safely in over 40 patients.

The company said the FDA has reviewed the “end-of-Phase I” data and will allow ACT to proceed with a Phase II human clinical trial.

The company plans to begin the Phase II human clinical trial for the treatment of heart failure in about 160 patients. If successful, the company expects to proceed with a pivotal Phase III trial. The company believes the Myoblast program may prove particularly beneficial for patients that have experienced a serious heart attack and have a high risk of heart failure.

“We now have three distinct programs in various stages of clinical and preclinical development,” said William Caldwell, IV, CEO/chairman of ACT. “Our Myoblast program for the treatment of heart failure will begin Phase II clinical trials shortly, while two of our human embryonic stem cell programs, our Hemangioblast program for treating blood and cardiovascular disease and our RPE program for treating retinal degenerative disorders, are in preclinical studies. We expect to file IND’s for those programs next year.”

ACT is a biotechnology company applying stem cell technology in the emerging field of regenerative medicine.

Eye care company Alcon (Huenenberg, Germany) reported that the company now holds 73.5% of WaveLight’s (Erlangen, Germany) outstanding shares through tender, contractual commitment or purchase. Additionally, the company reported that it received approval of the takeover from the Austrian Federal Cartel Authority.

The company continues to encourage WaveLight shareholders to tender their shares prior to the end of the offer period today.

Alcon recently amended its acquisition offer by removing the minimum acceptance threshold and extending the tender offer period through today. Its offer remains at 115 per WaveLight share which represents a 100% premium on the one-month (17.49), and a 118% premium on the three-month (16.88), volume weighted average stock exchange price as of the publication of the decision to launch the tender offer on July 16 (Medical Device Daily, July 17, 2007).

WaveLight’s products include the Allegretto laser system for refractive eye surgery.

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