A Medical Device Daily

Xceed Biotechnology (Melbourne, Australia) reported that its subsidiary company, PolyNovo Biomaterials, a developer of biologic polymers, has signed a partnering and license agreement with Medtronic (Minneapolis) to develop PolyNovo's NovoSorb for the treatment of cardiac and vascular disease, focusing on next-generation stent products.

NovoSorb is based on a composition of matter and process patents invented within the Division of Molecular and Health Technologies of the Commonwealth Science and Industrial Research Organisation (CSRIO) of Australia.

NovoSorb can be formulated either as an injectable gel that can be cured in situ or on demand, or as a solid with strength similar to bone. Degradation time can be preset according to use, from a few days to multiple years.

PolyNovo says that NovoSorb can be tailored to large markets with applications in stenting, orthopedics, orthodontics, drug delivery, wound care, tissue engineering, nerve regeneration and cartilage repair.

Biodegradable stents and stent coatings are forecast by the medical device industry to be the next generation products that will supersede existing drug-eluting stent devices. The stent market is currently estimated at about $4 billion annually, and predicted to grow to $7 billion a year by 2010.

PolyNovo's agreements with Medtronic have several key elements:

  • Up to $2 million in equity from Medtronic, based on clinical milestones.
  • Regulatory milestone and royalty payments to PolyNovo for products brought to market by Medtronic.
  • Medtronic providing PolyNovo a convertible loan of up to $3 million.

Other provisions include immediate investment by Xceed of A$3 million in PolyNovo, increasing its stake to 60%, CSIRO holding the remaining 40%; an option to Xceed to invest another A$2 million in PolyNovo at various prices over a two-year period; and an Xceed investment into PolyNovo, triggering CSIRO's assignment of its NovoSorb intellectual property to PolyNovo, previously subject to an exclusive licensing.

David Kenley, Xceed's CEO, said the agreements give “independent confirmation of the commercial value of PolyNovo's NovoSorb intellectual property. We will continue to work closely with PolyNovo to realize the market potential of NovoSorb in other medical device applications, including wound management, orthopedics and cell delivery.“

Xceed has worked with CSIRO to successfully spin off two companies: Boron Molecular, now 100% owned; and PolyNovo, now a 50% Xceed/CSIRO partnership, both launched with exclusively licensed/assigned technologies developed by CSIRO.

PolyNovo is focused on commercializing NovoSorb to produce a range of medical polymers that can be safely broken down by the human body.

In other financing news:

• Biophan Technologies (West Henrietta, New York), in a Securities and Exchange Commission filing, said it has received a $5 million credit facility from Biomed Solutions (Encinitas, California), a company headed by Biophan CEO Michael Weiner.

Biophan said it cannot use the $30 million financing committed to it by SBI Brightline XI (Irvine, California) until its registration statement is declared effective. The SBI financing results in an average price of $3 a share, assuming Biophan elects to sell all 10 million shares to SBI.

The Biomed facility gives Biophan access to up to $1.5 million monthly. Biomed will receive warrants to buy just under 1.2 million shares of Biophan stock at a 10% premium.

To acquire the capital to supply the credit facility, Biomed privately sold 4 million shares of stock and 1.18 million warrants.

Weiner said that Biomed “is willing to sell some of its holdings in order to provide Biophan with interim financing so Biophan's momentum is undeterred.“

Biophan develops technologies designed to make devices safe and image-compatible with MRI.

• PreMD (Toronto) reported receiving a C$638,000 from its marketing partner, McNeil Consumer Healthcare Canada, as a milestone payment related to development of its Prevu(x) Skin Sterol Test and is one of several milestones it expects to receive.

The Prevu(x) test assesses levels of skin sterol, with higher levels correlated with higher incidence of coronary artery disease. Prevu(x) is commercialized in the U.S., Canada and Europe by McNeil Consumer Healthcare, Canada.

PreMD's cancer tests include ColorectAlert, LungAlert and a breast cancer test. The company's R&D facility is at McMaster University (Hamilton, Ontario).

• Quest Diagnostics (Lyndhurst, New Jersey) said its board expanded its share repurchase authorization by $600 million, bringing the amount available for repurchase to $722 million. The company in 2005 repurchased 7.8 million common shares for $390 million; it had about 199 million shares outstanding as of Jan. 23.

The board also declared a quarterly cash dividend of 10 cents a common share, an 11% increase, payable on April 19.

Quest is a major provider of diagnostic testing, information and services.

• MedCath (Charlotte, North Carolina) reported that its subsidiary, MedCath Holdings, has completed an offer to purchase up to $30.33 million of 9-7/8% senior notes, due 2012.

MedCath Holdings paid for $11,865,000 principal amount of notes tendered prior to expiration. Holders who tendered notes prior to the expiration received, per $1,000 amount of notes tendered, of $1,000, plus unpaid interest on the notes tendered up to the payment date.

MedCath owns and operates hospitals in partnership with physicians, most of whom are cardiologists and cardiovascular surgeons.

• Steris (Mentor, Ohio) said its board authorized purchasing up to 3 million shares of its stock, replacing a previous authorization of about 150,000 shares. The board also approved a regular quarterly dividend of 4 cents a share, payable March 8.

Steris provides equipment, consumables and services to healthcare, pharmaceutical, industrial and government customers.

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