Tag - Medical

As technologies enable earlier diagnosis of cancer and other diseases, computer-aided detection systems (CADs), are critical to facilities such as women’s health-care centers that conduct mammograms to screen for breast cancer.

As one of the leaders in CAD technology used in the detection of breast cancer, Nashua, N.H.-based iCAD, Inc. (Nasdaq:ICAD) has enjoyed much investor interest in recent weeks, following news on April 4 that the U.S. Food and Drug Administration had approved a broader use of its technology. The clearance should put iCAD’s technology in thousands of additional mammogram machines by later this year.

ICAD stock, which started the year at $2.14 per share, closed at $3.60 on Friday, not far below its 52-week high of $4.24. Most analysts who follow the company see further room for growth as iCAD begins to recognize sales for its newly approved technologies for breast cancer detection, while working on ways to apply that same basic technology to the detection of other diseases such as colon cancer.

“They have a huge backlog of orders right now,” Jon Hickman, an analyst with MDB Capital Group, said in an interview with SmallCapInvestor.com. “They will keep making their existing products better and apply them to other cancers.”

The story of CADs in general (and iCAD in particular) is fairly complex, since these technologies do not work alone, but must be attached to a larger piece of equipment, such as a mammography machine.

The FDA, likewise, does not approve CAD technology in a vacuum. Rather, it reviews the safety and effectiveness of the technology when attached to a certain manufacturer’s equipment. ICAD’s big breakthrough last month was the approval of its SecondLook digital computer-aided detection system in FujiFilm Holdings Corp.’s digital mammography machines. The combination is aimed at screening for and diagnosing breast cancer earlier than the techniques now on the market.

Analyst Hickman projects sales from that iCAD/FujiFilm detection technology will reach $10 million to $11 million dollars within a year and a half. ICAD’s total revenues last year were $26.6 million, which offers some sense of the potential this latest . . .

www.makosurgical.com
Nasdaq: MAKO
Scheduled for the week of Feb. 11
$76.5 million estimated proceeds
$301.7 million estimated post-money valuation

Nothing cures arthritis like simply removing the troublesome joint and replacing it with a metal prosthesis. Hip and knee replacement surgery isn’t rare, but it isn’t simple, either: if there’s a problem, the patient may lose the use of that joint permanently. As the population ages, demand for joint replacement is likely to increase, so surgeons will want to find ways to handle the volume of surgery while ensuring that patients get the care they need.

MAKO Surgical has a different approach to knee replacement. The company uses a robotically guided surgical arm (using technology licensed from IBM (NYSE: IBM)) that works through a small incision in the knee. It resurfaces the trouble spot and installs a metal covering. This works best for people in the early stages of arthritis. The technology is FDA approved but very new. Six machines have been sold and 181 procedures have been performed commercially using this technique.

The financial results are just as early stage. For the nine months ended Sept. 30, 2007, MAKO posted just $355,382 in revenue (that’s 355 thousand, not million) and lost $13.2 million. One of the venture funders, Z-KAT, is selling a small amount of its position on the offering but will still control 7.02% of the shares after the IPO closes. Neither the other investors nor the officers are selling shares. The first $4 million of deal proceeds will go to IBM under the terms of the licensing agreement; the rest will be used to fund product marketing, research and development.

Hana Biosciences Inc. shares are (Nasdaq: HNAB) roaring upward since the biopharmaceutical company reported that its drug Marqibo has received fast track designation from the U.S. Food and Drug Administration.

Hana said its drug Marqibo, which is used for the treatment of adult patients with Philadelphia chromosome negative acute lymphoblastic leukemia (ALL) in second relapse or who have failed two lines of prior therapy,  is eligible for Fast Track designation because there is an unmet medical need in adult patients with the disease.

Earlier this year, Marqibo was also granted Orphan Drug Designation by the FDA for the treatment of adult ALL. Orphan Drug Designation is a program dedicated to the development of rare diseases.

ALL is a form of leukemia, characterised by overproduction and continuous multiplication of malignant and immature white blood cells in bone marrow. The disease could be fatal if left untreated, as it quicly spreads into the bloodstream and other vital organs. Approximately 4,000 cases of ALL are diagnosed annually in the United States.

Shares of Hana jumped 20.58%, or $0.28, to $1.64 in mid-day trading.

Shares of Home Diagnostics, Inc. (Nasdaq: HDIX) are falling this morning after the manufacturer and marketer of diabetes testing supplies reported weak second-quarter results below analyst expectations.

For the three months ended June 30, the Fort Lauderdale, Fla.-based company recorded earnings of $0.09 per share, below the $0.15 per share analysts were anticipating. The current quarter’s results compare with earnings of $0.11 for the second quarter last year.

“What happened in the quarter is that sales to distributors didn’t match out-the-door sales,” said Barrington Research analyst Derek Leckow. “Distributor days of inventory outstanding ran 50% below last year.”

Total revenue for the second quarter declined 1.7% to $28.1 million, also below analysts’ expectations of $30.3 million. Revenues for the second quarter of 2006 were $28.5 million.

Shares of Home Diagnostics tumbled 32.5%, or $3.69, on the news to a new 52-week low of $7.65 Thursday morning. Shares have been trading in a band of $9.88 to $13.20 for the past year.

Manufacturer and marketer of products for endoscopy Vision-Sciences, Inc. (Nasdaq: VSCI) this morning announced it swung to a profit in its fiscal fourth quarter.

For the three months ended March 31, 2007, the Orangeburg N.Y.-based company reported net income of $24 million, or $0.67 per diluted share, compared with a net loss of $1.1 million, or $0.03 per share, in the fourth quarter of 2006. The increase in earnings is attributed to a gain of $26.1 million on the sale of Vision-Sciences’ Ear-Nose-Throat EndoSheath product line to Medtronic Xomed, Inc. (NYSE: MDT), which closed in March 2007.

Vision-Sciences’ loss from operations widened to $1.6 million for the fourth quarter of 2007 from $1.2 million for the fourth quarter of 2006.

“We are pleased that we were able to complete the sale of our ENT EndoSheath product line to Medtronic,” said Vision-Sciences CEO Ron Hadani. “We anticipate that this transaction will enable us to focus on accelerating the development of new products and technologies, identifying potential acquisitions of related technologies, and entering new markets we have identified.”

Sales in Vision-Sciences’ medical segment increased 4% to $2.3 million in the fourth quarter, compared with sales of $2.2 million in the fourth quarter of 2006. For the fourth quarter revenues remained flat at $2.9 million, compared with the same fiscal quarter last year.