Arbios Systems has suspended operations and laid-off employees while it focuses on raising additional funds. If the company fails to secure financing by the end of August, Arbios will consider liquidating its assets.

Last May, Arbios began a pivotal trial for its SEPET liver assist device. The company received an Investigational Device Exemption from the FDA allowing the company to begin a pivotal clinical trial for SEPET in acutely ill patients suffering from chronic liver disease.

SEPET is a blood purification therapy designed for use with a standard blood dialysis system. It uses a sterile, single-use, disposable cartridge containing microporous hollow fibers that filter a patient’s blood and remove harmful impurities like ammonia. These substances would otherwise accumulate in the patient’s bloodstream during liver failure, accelerating damage to the liver and other organs.

Liver and biliary diseases affect 25 million Americans, whose annual healthcare costs exceed $10 billion. Unfortunately, there are no direct treatments available for liver failure and patients must receive a liver transplant or endure prolonged hospitalization with significant mortality.

7 August 2008 | Blog, news2 | Douglas Cress | No Comments

Not wanting to break a winning streak, Clarient delivered its 16th consecutive quarter of quarterly revenue growth. The company posted revenues of $16.9 million in its most recent quarter, a 71% increase over the same period last year.

Based on performance in the first half of 2008, Clarient raised fiscal year 2008 revenue guidance to $62 - $66 million, from guidance of $56 - $60 million.

According to the company, the increase in revenues was driven by higher testing volume, a favorable service mix and higher Medicare reimbursement rates. Clarient continues to acquire and retain customers.

Testing volumes for the second quarter of 2008 increased by 60% year-over-year, largely a result of breast prognostics (Clarient is on track to launch its Insight Dx Breast Cancer Profile in the second half of 2008). Solid tumor testing volume increased 30%, leukemia/lymphoma volumes increased 86%, and PCR/molecular testing increased 98%.

Clarient services include: diagnosing solid tumors, cancer sub-typing, classifying patients into prognostic categories (i.e. low, medium and high risk groups), identifying which drugs or therapy paths are best for patients, monitoring patient on therapy, searching for residual disease during and post therapy, and detecting relapse or cancer transformation.

Volume growth and higher reimbursement drove gross margins of 59 percent, a huge improvement over the 44 percent gross margins reported in the second quarter of 2007. Clarient also pointed to increased employee productivity and lower fixed costs.

Q2 2008 gross profit was $10.0 million, an increase of 129% compared with $4.4 million in Q2 2007.

This interview with Ron Andrews was filmed in January 2008 at the OneMedPlace Finance Forum.

7 August 2008 | Blog, Member Spotlight, news1 | Douglas Cress | No Comments

NeuroMetrix reported quarterly revenues of $8.5 million yesterday, down approximately 26% from the same period in 2007.

The company generated a scant $510,000 (or 6% or revenues) from the sale of devices, including NC-stat System and the newer Advance. That could spell trouble for future earnings: during the last quarter, the company’s active customer count, a twelve-month look at accounts utilizing the company’s neurodiagnostic instruments, decreased by about 100 to 5,480 physician practices and clinics.

As device sales stagnate and the active customer count slides, the cash-generating consumables business will also suffer. In the most recent quarter, a full 90% of revenues (or $7.6 million) came from the sale of biosensors, the consumable portion of the beleaguered NC-Stat system. Consumables kept gross margins high, a robust 70.7% of revenues.

Shai Gozani, NeuroMetrix President & CEO, said that business was adversely impacted by uncertainty surrounding reimbursement for nerve conduction studies performed using the NC-stat System. According to Gozaini, NC-stat revenues may continue to decline during 2008.

For the time being, the company is focusing sales efforts primarily on specialist physicians with peripheral nerve expertise. Consistent with that strategy, the company launched the Advance System in late May following its 510(k) clearance by the FDA.

The net loss for the second quarter of 2008 was approximately $4.9 million, including a write-down of $1.4 million of an investment in Cyberkinetics Neurotechnology. The company lost $1.3 million in Q2 2007. Cash and cash equivalents totaled $22.8 million as of June 30, 2008.

Previously: NeuroMetrix Cost Cutting and Product Introductions Not Enough to Appease Investors

6 August 2008 | Blog, news1 | Douglas Cress | No Comments

Chembio Diagnostics reported second quarter revenues of $2.72 million, an 8.6% increase over Q2 2007 and higher than any previous quarter. The lion’s share of revenues came from the company’s rapid HIV test; sales were $2.21 million in Q2, up $61,500 year-over-year.

Net loss was $363,000 or $0.01 per share in the second quarter of 2008. The company lost $983,000 in the same period last year.

Lawrence Siebert, President and CEO, saw continued improvements in the company’s base lateral flow business; revenue from the company’s Dual Path Platform (DPP) products are close to being realized.

DPP offers significant advantages over traditional Lateral Flow assays. The independent flow paths of the DPP increase the efficiency of antibody binding to the immobilized antigen. This results in improved sensitivity and faster testing. DPP is also well suited to a variety of testing media including blood, serum, urine, feces or saliva. In conventional LF assays some samples will migrate slowly. With DPP technology, sorbent materials are utilized to permit faster migration and faster results.

Previously: [Video] New Developments at Chembio Diagnostics

5 August 2008 | Blog, Member Spotlight, news2 | Douglas Cress | No Comments

In this video, Keay discusses Greatbatch, which he believes is a compelling buy based on its current valuation.

Keay also discusses Stereotaxis. The company has had a hard time getting its catheter, which treats irregular heartbeats, to market (a small number of the devices exhibited signs of char or coagulum formation). The catheter was delayed for about a year.

Previously: [Video] Medical Device Market Overview: Interview with Keay Nakae, Analyst at Collins Stewart

4 August 2008 | Blog, news2, feature2 | Douglas Cress | No Comments

Some insightful commentary care of Keay Nakae, the medical device analyst at Collins Stewart. We spoke to Keay earlier this month at the firm’s annual growth conference in New York.

4 August 2008 | Blog, news1, feature1 | Douglas Cress | 1 Comment

Electro-Optical Sciences (EOS), developer of The MelaFind System, a hand held imaging device that detects melanomas at an early stage, has completed patient accrual in its blinded pivotal trial.

The trial will serve as the basis for the company’s Pre-Market Approval (PMA) application with the FDA. Conducted at seven centers in the U.S., EOS has enrolled some 1,300 patients and will evaluate over 1,800 suspicious lesions. All suspicious lesions are biopsied and sent for dermatohistopathologic analysis.

In a previous blinded trial examining 352 suspicious pigmented skin lesions, MelaFind had 100% sensitivity in finding a melanoma and achieved 48.4% specificity (compared with the study dermatologists’ sensitivity of 96.4% and specificity of 28.4%). Specificity, in this case, is the probability that an individual who does not have melanoma will be correctly identified as negative; high specificity reduces the need for biopsies.

With assistance provided by MelaFind, physicians could diagnose more melanomas at the earliest curable stage, reducing both treatment costs and the number of unnecessary biopsies. Joseph Gulfo, EOS President and CEO, describes MelaFind as “better, cheaper medicine”.

Results of the pivotal trial are anticipated in the fourth quarter, with PMA filing to follow.

Previously: [Video] Interview with Joseph Gulfo, President and CEO of Electro-Optical Sciences

4 August 2008 | Blog, news2 | Douglas Cress | No Comments

Langer, Inc. has completed the sale of Bi-Op Laboratories for $2,125,000 in cash. Buyers include a group of investors and Raynald Henry, the current Bi-Op GM.

The Bi-Op sale is part of Langer’s stated strategy of simplifying the company’s business and reducing corporate and compliance expenses. As part of this effort, Langer divested its UK subsidiary to Sole Solutions for $1.2 million in cash and notes.

2007 was a challenging year for Langer; the company seems to have lost focus in an attempt to grow aggressively. While Langer’s Silipos subsidiary performed well, its newly acquired Twincraft and Regal businesses did not. Blame the economic downturn, perhaps. The cost of maintaining these businesses on a corporate level remains high relative to profits.

Langer, which provides long-term care, orthopedic, orthotic and prosthetic products, acquired Bi-Op in 2003 to gain access to additional markets and complementary product lines (Bi-Op offers footwear and foot orthotic devices as well as orthotic and prosthetic services). Including transaction costs, the purchase price was approximately $2.2 million, paid in cash and stock.

Langer’s Twincraft and Silipos subsidiaries offer a diverse line of bar soap and skincare products.

1 August 2008 | Blog, news2 | Douglas Cress | No Comments

Some older news, in video form, care of our team at OneMedPlace TV.

Thermage announced it would acquire Reliant Technologies earlier this month. The stock and cash transaction was valued at ≈ $95 million and combines respective leaders in skin tightening and skin resurfacing, two fast-growing segments of the aesthetics industry.

Thermage and Reliant generated nearly $137 million in revenue on a combined basis for the 12 months ended March 31, 2008. The transaction is expected to create cross selling opportunities in domestic and international markets.

31 July 2008 | Blog, news1, Video, feature2 | Douglas Cress | No Comments

The Radiology Group has developed a virtual, full-service radiology department with a complete range of specialty interpretations. The company aims to match the appropriate physician with the appropriate exam in an effort to raise the standards of health care imaging while lowering costs.

Services include the complete management of radiology department (dictation, reports and billing) and the placement of an on-site radiologist in combination with subspecialty remote needs. Physician clients can expect 24/7 remote coverage with final reports by board-certified subspecialty radiologists.

31 July 2008 | Blog, Video | Douglas Cress | No Comments