Biotech Values

[DewDiligence]

CABG Medical Announces Update on Clinical Trial

[CABG has been a textbook case of the “cockroach theory” of investing: you never see a single isolated cockroach, and you rarely encounter a single isolated bout of bad news with an emerging-stage biotech company.

CABG was hammered in August (#msg-7235795) when their first clinical data showed that the novel device for CABG surgery didn’t work. The company said it would rework both the device and the implantation procedure, and two weeks ago they issued a suspicious-sounding PR that I questioned (#msg-8342983). Finally, yesterday, they admitted that the fix doesn’t work either. Today, the stock was down 41%, and that’s a lot cockroaches.]

http://biz.yahoo.com/prnews/051115/cgtu089.html?.v=4

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Tuesday November 15, 4:15 pm ET

MINNEAPOLIS, Nov. 15 /PRNewswire-FirstCall/ -- CABG Medical, Inc. (Nasdaq: CABG - News) today announced the completion of enrollment in the first arm of its international clinical trial of the Holly Graft(TM) System (HGS), a drug eluting graft (DEG) for facilitating a coronary artery bypass procedure. This first enrollment arm consisted of 35 patients implanted with the HGS and treated with an anti-platelet regimen of aspirin and clopidogrel (Plavix). Twelve grafts have been determined to be occluded and nonfunctional. Additionally, two patients have experienced adverse events, including one death that was determined not to be related to device performance and one adverse event in which the Holly Graft System was removed from the patient prior to the completion of the surgery. The majority of the remaining 21 patients have been examined prior to discharge and, to the Company's knowledge, are in good health. The Company does not know whether these grafts continue to be functional. None of these patients have undergone a long-term follow-up examination and the ultimate efficacy of the device cannot be assessed until such data is collected.

The next enrollment arm, which has already been initiated, will consist of five patients. The clinicians will treat these patients with an anti-coagulant regimen of aspirin and warfarin rather than aspirin and clopidogrel. The Company will follow these patients for 60 days to evaluate the efficacy of the aspirin and warfarin regimen. If the initial results from these patients is positive, this arm will be expanded to include a total of approximately 30 patients. The Company expects the clinical endpoint of the study to be six-month follow-up, with graft patency to be determined by angiography.

"Our initial results do not meet the standards necessary to obtain regulatory product approvals allowing distribution of the Holly Graft System to the general population of bypass patients," [quite an understatement!] commented Manny Villafana, the Company's Chairman and Chief Executive Officer. Mr. Villafana added, "We hope to improve our clinical results in the second phase of our clinical evaluation. Our intention at the conclusion of this second phase of clinical trials is to gather the data on the two anti-coagulation regimens to assess their relative efficacy as a treatment modality for Holly Graft implantations. We will also seek to make such product improvements as are deemed necessary to arrive at an optimal graft design for all bypass patients."

About CABG Medical

CABG Medical, Inc. is a medical technology company developing technologies and therapies to improve the treatment of coronary heart disease by advancing conventional bypass surgery.
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