Archives for October 2008
FDA Approves ATS Medical’s 3f Aortic Biprosthesis, 3f Enable Still in the Works
The FDA has approved ATS Medical’s 3f Aortic Bioprosthesis (3fAB), a poorly named, but potentially revolutionary pericardial aortic tissue valve.
3fAB’s blood flow dynamics and improved stress distribution mimic the functional characteristics of the native valve, offering patients a more durable aortic valve replacement. Six years of clinical experience confirm safety and efficacy.
“The ease of implantation and potential for longer term durability makes this an excellent choice for my patients,” said Dr. Richard Shemin, Chief of Cardiothoracic Surgery at UCLA’s Med School.
Two years ago, ATS acquired 3F Therapeutics, a privately held developer of tissue heart valve products for $58 million. The acquisition brought less-invasive surgical technology to ATS and opened the door to the $400 million U.S. tissue valve market.
A second generation valve, the 3f Enable Aortic Bioprosthesis (Enable) is currently under clinical investigation; ATS submitted an IDE in March 2007.
The Enable
Clarient: Q3 Revenues up 59%; Raises Guidance
Third quarter revenues at Clarient increased 59% to $19.0 million from the $11.9 million reported in Q3 2007. This marks the company’s 17th consecutive quarter of sequential revenue growth. Higher testing volume, a favorable service mix and higher Medicare reimbursement rates drove revenues.
Testing volume for the third quarter of 2008 increased 53% year-over-year. The company will add several new growth drivers in coming months. These include the launch of the long awaited Insight Dx Breast Cancer Profile, and the introduction of the Insight Dx Prostate Profile, licensed from Health Discovery Corporation. In September, Clarient announced that, with Definiens, it will develop and commercialize tools to help evaluate quantitative biomarkers that predict cancer treatment response.
Clarient has also announced its intention to expand its sales and marketing infrastructure. The company will hire additional sales reps to cover previously underserved territories. Confident in its
[Video Profile] Sherlock-NMD
When an athlete is injured, their career and value to the team are at risk. At all levels of athletics, including everyday fitness enthusiasts, the frequency and severity of injuries makes it imperative to find better methods to identify and treat biomechanical muscular skeletal dysfunctions.
Currently, the most widely used diagnostic tools for muscular skeletal injuries are X-rays and MRI’s. These are static diagnostic tests, done with the patient standing or lying still. Although this is necessary for the identification of bone breaks, fractures and muscle tears, it is not optimal for the diagnosis of mechanical dysfunctions. Muscular skeletal injuries occur while moving. An accurate diagnosis of injuries that occur while moving requires a diagnostic system that analyzes movement.
Sherlock-NMD has developed a non-invasive biomechanical diagnostic system that can record and analyze human range of motion in a full 3D environment. The system
Cynosure: Profitable, Growing and Flush with Cash, but Investors Don’t Care
Quarterly revenues at Cynosure, a developer of laser-based aesthetic systems, grew 21% year-over-year, from $31.5 million in Q3 2007 to $38.2 million in the most recent quarter. Second quarter revenues were $39.2 million.
Net income for the third quarter of 2008 was $3.2 million compared with net income of $4.4 million for the same period last year. The decline in profits was largely the result of a foreign currency exchange loss of $0.4 million. In Q3 2007, the company reported a foreign currency exchange gain of $0.5 million.
Cynosure, profitable for eight consecutive quarters, seems comfortable navigating the challenging economic conditions seen throughout the aesthetics industry. President and CEO Michael Davin commented, “[A] consistent focus on innovation enabled us to extend our leadership position. Driving our performance was steady demand for our Elite workstation for laser hair removal, our Affirm workstations for anti-aging
Langer Sheds Orthotics Business to Cut the Fat
Only months after Langer sold its Bi-Op subsidiary for less than its purchase price, the company announced the sale of its custom orthotics business to The Orthotic Group (TOG), a manufacturer of prescription custom foot orthotics, orthotic footwear and gait analysis equipment. TOG paid approximately $4.7 million in cash at closing. The deal includes Langer’s Deer Park, NY facility as well as its sales office in Markham, Ontario.
Net proceeds, after transaction costs, are $4.1 million. Langer expects to recognize a minimal gain on the sale.
The selling 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 the company; Langer seems to have lost focus in an attempt to grow aggressively. While
Nothing But Sunshine and Roses for Endologix, Save its Share Price
Endologix, developer of a treatment for abdominal aortic aneurysms (AAA), saw revenues increase 42% in its third quarter. The company reported $9.4 million in sales and expects “at least” $10 million in fourth quarter revenue. If all goes to plan, Endologix is on track for full-year sales growth of 38% or more.
It’s been nothing but sunshine and roses for the company, which is now considering a $98 million buyout from hedge fund Elliott Associates. Endologix has received two new FDA clearances in as many weeks, further positioning the company for long term growth.
During the third quarter the company significantly improved its liquidity position and remains confident that it will begin generating positive operating cash flow in the first half of 2009.
For the nine months ended September 30, 2008, total product revenue increased 41% to $27.0 million, compared with $19.1 million for the nine
Candela Explores Strategic Alternatives in Challenging Aesthetics Market
First Quarter Results:
Revenues at Candela Corporation, a maker of aesthetic lasers, decreased 24 percent year-over-year, to $26.9 million in the most recent quarter from $35.5 million last year. The decrease in revenues took its toll on the bottom line: the company reported a net loss of $4.0 million. In the same period last year the company had net income of $187,000.
While service revenues grew slightly ($9.6 million in the most recent quarter, compared to $8.6 million in Q1 2007), sales of lasers and other products dropped significantly. The company recorded $17.2 million in sales this quarter, compared to $26.8 million in the same period last year.
Gerard Puorro, Candela’s President and CEO, blamed challenging economic and business conditions in the laser aesthetics industry – though he expects things will get better with time.
In light of the stock’s precipitous decline, the company
MDMA
Business as Usual for Endologix as it Considers $98 Million Buyout
More good news from Endologix, the Irvine, CA-based company mulling over a $98 million buyout bid from hedge fund Elliott Associates.
This week, the company’s IntuiTrak Delivery System was approved by the FDA. The System will be used to deliver and deploy the company’s stent graft, for the endovascular repair of abdominal aortic aneurysms (AAA). Endologix plans to conduct a limited market release over the next several months, followed by a full commercial U.S. launch in Q2 2009.
IntuiTrak simplifies delivery of the Powerlink device. The low-profile delivery system is more flexible and smoother, thanks to a hydrophilic coating. The new catheter also offers an integrated sheath to facilitate the introduction of ancillary devices during the endovascular AAA procedure.
That news follows last week’s FDA approval of Powerlink XL, which broadened the company’s treatment indications to include AAA patients with proximal aortic necks
NxStage Medical Signs Long-Term Supply Agreement with Renal Advantage
NxStage Medical has signed a long-term product supply agreement with Renal Advantage (RAI), the fourth largest provider of dialysis services in the U.S. Under the terms of the agreement, NxStage will supply the Streamline airless blood tubing set, MasterGuard and other products to RAI’s dialysis center network.
Streamline is designed to reduce treatment time, minimize heparin use and optimize dose delivery. Streamline also includes LockSite needleless access ports, which eliminate the need for sharp needles or costlier guarded needles to be used with the tubing set during dialysis.
“As part of a diligent evaluation process in our centers, Streamline showed its ability to improve patient clearances, reduce costs, and enhance staff satisfaction,” said Dean Weiland, COO of RAI. The relationship could also expand the reach of NxStage’s System One.
RAI was a long-term Medisystems customer. In June 2007, NxStage paid $78.7 million for the company
