Shares of ThermoGenesis
In conjunction with the management changes, ThermoGenesis pre-announced record revenues exceeding $5 million for its fiscal third quarter ended March 31. This latest announcement of record revenues follows a company press release from early March, wherein the company announced that its contract manufacturers had increased weekly production of disposable bags used with the company's umbilical cord blood stem cell processing equipment.
ThermoGenesis was previously experiencing a backlog of orders for the bags, which are used with the AutoXpress System marketed by GE Healthcare. This order backlog was blamed for the company's disappointing second-quarter results reported in early February, which precipitated the company's gradual decline from around $4 per share to a yearly closing low of $2.69 on March 13.
Looking ahead, ThermoGenesis has a pending 510(k) pre-market notification application submitted to the FDA for its AutoXpress System (AXP). This application stems from a recent FDA announcement of its intention to start regulating cord blood processing systems. The AXP is currently being marketed and sold worldwide to cord blood banks by partner GE Healthcare to automate the isolation and collection of umbilical stem cells.
Another pending FDA application involves the company's CryoSeal FS System, which is used to prepare surgical fibrin sealants (used to control bleeding) from a patient's own plasma in about an hour. ThermoGenesis announced in early February that it had fully responded to a set of FDA inquiries regarding CryoSeal. The company's pre-market approval application for the CryoSeal Fibrin Sealant System as an adjunct to hemostasis in liver resection surgeries is based on findings from a clinical study involving 150 patients. Biomet
Shares of ThermoGenesis are currently trading at compelling levels that could produce nice gains if the company receives FDA approvals and subsequently ramps up the sales of its umbilical cord blood stem cell processing machines and ancillary products. As the company moves toward profitability (expected in about a year), investors now have a chance to buy shares at a KOOL discount to insider purchases last May, when executive Philip Coelho and director Dr. Hubert Huckel snatched up 75,000 shares at around $4 per share.
Fool contributor Mike Havrilla, R.Ph., B.S., Pharm.D., is a Rite Aid pharmacist who lives and works in the small Pennsylvania town of Portage. He invites your comments and feedback. Mike does not have a position in any company mentioned here. The Fool has a disclosure policy.