Early-stage firm ATI Medical (San Diego, California) has won 510(k) clearance for its IsoRod technology, a system for "seeding" and then, if necessary, ablating unwanted tissue, with its first target the prostate. That initial focus is for a type of cancer that sees a high rate of failure in other therapies, Tate Scott, president and CEO of ATI, told The BBI Newsletter. And he notes that this is a situation that provides both an important new follow-up treatment option for patients and a large opportunity for the IsoRod system.

"There are a lot of different ways to treat prostate cancer," Scott says, "but what do we do if [a treatment] fails?" a scenario he terms "a key problem in this market." Scott goes on to describe the ambiguous and anxiety-producing options and alternatives confronting men with enlarged prostates or slow-growing prostate cancer and facing the initial choices usually offered to them: primarily external beam radiation or the implanting of radioactive seeds. In both cases, the failure rates run as high as 20%, he says.

With a failure, follow-up to radiation of either kind is ordinarily impossible via surgery, he notes: "The tissue plains are very difficult to identify, and you can end up taking tissue you don't want to take." And the combination of surgery first, followed by salvage radiation afterwards is equally tricky and hardly fail-safe. What therefore is needed is a system that allows a treatment that enables a workable and effective follow-up and that is where IsoRod comes in, offering just such an option.

ATI's radioactive seeds also contain a small rod-like structure made of ferromagnetic material. This additional component means that after the radioactivity of the seeds has "half-lifed" away, the seed-cum-rod can again be used to retreat the prostate, if necessary, via heat. This is done while the patient is under anesthesia, with an electromagnetic field being used to "turn on the thermal portion of the rod," Scott says. This, in a sense, reactivates the seeds but "in a different way the second time." By simply "flipping a switch," he says, the clinician is able to perform what is, in essence, a sort of therapeutic mulligan.

Besides offering an easy type of follow-on therapy, the IsoRod technology offers clear marketing advantages as well, Scott says. "It's a therapy that works just like every other [seed implantation] therapy on the market," he notes, so ATI has built-in reimbursement coverage. And no reimbursement coverage will be needed for the follow-on reheating treatment since ATI will make no additional charges for that if it becomes necessary, Scott explains.

The therapy is CE-marked in Europe, and the initial clearance in the U.S. is for implantation and tissue ablation alone. The company's next step will be to pursue labeling specifically for treatment of cancer. In support, the company is conducting a clinical trial at various international and domestic sites, with 20 patients already treated in the U.S. Scott describes the initial results as "spectacular," and the company hopes to apply for premarket approval clearance specifically for cancer therapy sometime next year.

Since the treatment is for localized cancers, the possibilities of other applications are both numerous and enticing. "The liver, kidney and breast are areas we can go to next," Scott says.

Venture-backed ATI has put up to $15 million thus far into the IsoRod technology, Scott reports. Developed at the University of Iowa (Iowa City, Iowa), its inventor is Robert Tucker, MD, PhD, who then licensed it from the university and later licensed it to ATI. Investors to date include Domain Associates, Inglewood Ventures and Johnson & Johnson Development.

Scott also sees the company as a likely acquisition target for others in this sector but lays out no plans for exit quite yet. "We're ready to rock and roll," he says. "We need to expand marketing activities and we're extremely excited about this. This is the first really different seed in the market."

Elsewhere in the product pipeline:

Aventis Behring (King of Prussia, Pennsylvania) said a procedure for cleaning the production equipment of plasma-derived therapies has the capacity to eliminate the theoretical risk of prion contamination, according to a new study published in a supplement of Blood, the official publication of the American Society of Hematology. Prions are infectious proteins thought to cause neurodegenerative disorders, such as bovine spongiform encephalopathy (BSE), otherwise known as "mad cow" disease, Creutzfeldt-Jakob Disease (CJD) and its variant form, vCJD.

Boston Biomedica (West Bridgewater, Massachusetts) said it has been issued a U.S. patent covering devices used in its proprietary pressure cycling technology (PCT) for determination of nucleic acid and protein sequences. The "Integrated Sequencing Device" patent (No. 6,448,065) is based on the finding that pressure can be used to control the activity of enzymes that break down DNA and proteins into nucleotides and amino acids. The patent describes a self-contained high-pressure reaction and detection apparatus with an integrated pressure cycling device optimized for sequencing operations, and it extends the coverage of an earlier patent with the same title (No. 6,245,506) that described the sequencing methodology. Boston Biomedica also reported the grant of its first two European patents, for "Pressure Cycling Reactor" and "Pressure Mediated Binding of Biomolecular Complexes."

Bristol-Myers Squibb Medical Imaging (North Billerica, Massachusetts) said a study published in the Journal of the American Medical Association reported that the addition of its Cardiolite (Kit for the Preparation of Tc99m Sestamibi for Injection) noninvasive heart imaging test can help doctors in the emergency department better distinguish between those patients who are having a heart attack and those who are not. Researchers say the results of this study could serve as the basis for a new standard of care for chest pain assessment in emergency departments. A Cardiolite imaging test, also called sestamibi imaging, allows doctors to noninvasively evaluate the heart's pumping ability and gauge the amount of blood flow to the heart muscle itself and thus can quickly assess whether or not a patient is having a heart attack. Researchers participating in the Emergency Room Assessment of Sestamibi for Evaluation of chest pain (ERASE) trial evaluated 2,475 patients with symptoms suggestive of heart attack or acute cardiac ischemia who had a normal or non-diagnostic ECG. Among patients who received Cardiolite, unnecessary hospitalizations were reduced by 20% among patients without acute cardiac ischemia, without reducing appropriate admissions for patients with acute ischemia.

Calypte Biomedical (Alameda, California) said it has executed a memorandum of understanding (MOU) with the Safe Blood for Africa Foundation, giving it exclusive rights to market and distribute Calypte's urine-based HIV-1 antibody tests in sub-Saharan Africa as a blood donor pre-screening tool. Non-exclusive rights to distribute the company's Serum Western Blot tests also are included in the MOU. Provided certain milestones are achieved, it is anticipated, the company said, that the MOU will become a formal distribution agreement in three months, at which time the agreement will automatically become a 10-year distribution contract.

CTI Molecular Imaging (Knoxville, Tennessee) said that its CPS Innovations unit has been granted a method patent by the U.S. Patent and Trademark Office in connection with its development of the positron emission tomography/computed tomography scanner. PET/CT combines the metabolic imaging of positron emission tomography with the anatomical imaging of computed tomography. The system combines PET and CT technology into one system to produce a single image of both metabolic function and anatomic structure to more accurately identify the precise location of abnormalities in the body, according to CPS.

Dade Behring (Deerfield, Illinois) said that testing blood for the presence of C-reactive protein, in conjunction with cholesterol testing, could be an important means of identifying persons at risk of developing heart disease, according to a study published in a recent issue of the New England Journal of Medicine. The study is the largest to date on the use of C-reactive protein in cardiac risk assessment, and involved 27,939 women over the mean course of eight years. It reported that "because C-reactive protein and LDL cholesterol measurements tended to identify different high-risk groups, screening for both biologic markers provided better prognostic information than screening for either alone." Dade Behring also has introduced a new assay for the direct measurement of low-density lipoprotein (LDL) cholesterol for its Dimension clinical chemistry system. The Automated Low Density Lipoprotein (ALDL) test aids in the diagnosis and monitoring of cardiovascular disease, with studies having shown that high levels of LDL significantly increase the risk for coronary heart disease, which accounts for more than half of all forms of cardiovascular disease. Dade Behring said the ability of its test to directly measure LDL rather than it being estimated indirectly according to a formula will allow laboratories to attain a more accurate reading, particularly among patients with high levels of triglycerides, where it said the mathematical calculation is particularly inaccurate.

Delcath Systems (Stamford, Connecticut) reported three of four patients who completed all planned treatments with its experimental cancer technology at the National Cancer Institute (NCI; Bethesda, Maryland) achieved results ranging from disease stabilization to complete response. In a report to the company, NCI researchers further said that four of 11 patients enrolled in its dose-finding study had undergone all four planned treatments. Results in three of the patients included a complete response, a partial response and disease stabilization. The fourth patient was awaiting response assessment. The study is testing the approved cancer drug melphalan with Delcath's drug delivery system in patients with inoperable cancer of the liver. The delivery system uses specially configured patented catheters to isolate and perfuse single organs or a region of the body with high doses of toxic drugs, allowing only minimal amounts to enter general circulation. The highly controlled drug delivery allows cancer-killing agents to be administered at much higher doses than would normally be achieved by conventional methods, the company said. The NCI is planning a Phase II study with the Delcath system and melphalan to treat patients with three kinds of metastatic liver cancer.

Diomed Holdings (Andover, Massachusetts) said last month that it received FDA approval for expanded indications for use of Endovenous Laser Treatment (EVLT), including its D15plus and D30plus diode lasers and disposable kits for the treatment of varicose veins and varicosities associated with the superficial vein reflux of the greater saphenous vein. In January 2002, Diomed received FDA clearance for the use of EVLT for the closure of the greater saphenous vein with superficial reflux. Diomed is the first company to receive FDA clearance for the laser-based treatment of varicose veins. Diomed also said that Axcan Pharma, its photodynamic therapy (PDT) collaborative partner, has received an "approvable" letter from the FDA for its drug Photofrin, used in conjunction with Diomed's 630nm PDT laser and Optiguide disposable fibers, in the treatment of high-grade dysplasia associated with Barrett's esophagus.

Dolphin Medical (Hawthorne, California), a majority-owned subsidiary of OSI Systems (Atlanta, Georgia) reported that its new Dolphin Voyager has received 510(k) approval from the FDA. The Dolphin Voyager is a pulse oximetry engine designed in the standard compact flash format. The card slides into any compact flash socket and, with the accompanying Dolphin ONE (Oximetry Noise Elimination) software, provides the user with a fully functional pulse oximeter. The Voyager is FDA-approved and CE marked for use with the Compaq iPAQ 3600, 3700 and 3800 series pocket PCs. The Voyager is designed to be a high-performance, motion-tolerant, low perfusion-tolerant pulse oximeter in a portable package with the convenient compact flash format. It features real-time display of patient waveforms and easy-to-use SpO₂, pulse, and perfusion trending.

Norwood Abbey (Melbourne, Australia) said a needleless injection device has been created under the direction of Professor Ian Hunter at the Massachusetts Institute of Technology's (MIT; Cambridge, Massachusetts) BioInstrumentation Laboratory through a sponsored research agreement with the company. The needleless injection device relies on technology originally developed by Hunter while he was affiliated with McGill University (Montreal, Quebec), so Norwood also has entered into a licensing agreement with McGill in relation to the device's underlying shape memory and has lodged provisional patent applications covering key aspects of the technology. Norwood has worldwide rights to the device.

OmniSonics Medical Technologies (Wilmington, Massachusetts), a developer of products to treat vascular occlusive disease based on its OmniWave technology platform, said it received the CE mark in the European Union for the Resolution 360 Therapeutic Wire. The company received its first CE mark in June for its Resolution System, which delivers low power, acoustic energy 360 degrees around the active length of the wire to rapidly resolve blood clots, or thrombus, into micro-particles smaller than red blood cells. With this second CE mark, OmniSonics said it now can market the Resolution System and 360 Therapeutic Wire in the EU, initially for the treatment of lower extremity thrombotic occlusions and thrombosed hemodialysis fistulae.

Parallax Medical (Scotts Valley, California) reported limited market release of its Core-Assure Bone and Vertebral Body Biopsy Kit. It said the kit enables improved core tissue sample quality and capture with maintained access to the vertebral body for subsequent procedures. The kit was to be available in late December for shipment to physicians throughout the U.S., Parallax said. The Core-Assure kit offers benefits over existing technologies, the company said, because the funnel needle tip design facilitates reliable core tissue sample capture during a bone biopsy procedure, without what it referred to as "the multiple capture attempts to obtain a good quality core tissue sample typical of current devices."

PerkinElmer (Boston, Massachusetts), a provider of drug discovery, life science research, laboratory tools and genetic screening solutions, reported the availability of GAD65 Ab and IA-2 Ab autoantibody kits for monitoring individuals at risk of Type 1 diabetes, often referred to as "juvenile" diabetes. The Delfia GAD65 Ab and Delphia IA-2 Ab commercial assays, approved for research in the U.S., will enable pharmaceutical companies, together with research groups, to search for possible drug candidates for a cure of Type 1 diabetes much faster than ever before.

Smith & Nephew (S&N; Memphis, Tennessee) reported the release of a new computer-assisted navigational instrument set enabling surgeons to perform complex, traditionally invasive trauma surgeries, such as femoral and pelvic fracture fixation, through quarter-inch incisions. The Achieve brand instrument set is an advancement of a previously available computer-assisted system with which surgeons may be able to reduce surgery duration, radiation exposure, blood loss and rehabilitation time while increasing surgical accuracy, S&N said. The company recently received FDA 510(k) clearance for its use in fracture reduction procedures and high tibial osteotomies.

Smith & Nephew Endoscopy (Andover, Massachusetts), a subsidiary of Smith & Nephew plc (London), reported the introduction of TwinFix Suture Anchors with Needles, an anchor inserter and needle delivery system for soft-tissue reattachment in the shoulder and in other joint procedures. Designed to be used in open, mini-open and arthroscopic surgical procedures, TwinFix Suture Anchors with Needles has two dual-armed sutures providing surgeons with greater speed and flexibility in reattaching soft tissue to bone. A protected suture path also prevents binding or twisting of the suture around the inserter shaft. TwinFix Suture Anchors with Needles also uses a patented, double-helix Hi-Lo thread pattern to ensure that the anchor deploys into and is retained across the wide variations in patient bone densities and tissue quality, the company said.

STAAR Surgical (Monrovia, California) said it has received the CE mark for the Toric Implantable Contact Lens (TICL). The TICL is the only posterior chamber phakic intraocular lens able to both reduce pre-existing astigmatism and provide correction of myopia (nearsightedness) or hyperopia (farsightedness) in one procedure, the company said. According to industry sources, approximately 20% of the population suffers from astigmatism, a corneal irregularity causing impairment of sight, with the percentage much higher among severely myopic and hyperopic patients. STAAR Surgical received conditional approval to initiate clinical investigation by the FDA last January and implanted the first TICL in a patient's eye in August, with excellent results, it said.

St. Jude Medical (St. Paul, Minnesota) reported its worldwide commercial launch of its next-generation Epic VR and DR implantable cardioverter defibrillators (ICD), the smallest, lightest ICDs to deliver 30 joules of energy, it said. The St. Jude Medical Epic VR and DR ICDs represent the second product family of new ICDs introduced by the company this year, following the first-quarter launch of the Atlas ICD product line. The Atlas ICD family, which currently represents about 80% of St. Jude's ICD sales, helped fuel a 52% growth rate in ICD revenues in 3Q02. The company received FDA approval of the Epic ICD products in July, implanted the first U.S. device in August and began a limited launch in September. In Europe, the Epic ICDs received CE marking in October, with first implants occurring on Dec. 2 at the Rouen University Hospital (Rouen, France).

Synthetic Blood International (Costa Mesa, California) said the company has received all results from animal studies involving Oxycyte, the perfluorocarbon-based (PFC) blood substitute and therapeutic oxygen carrier the company is developing. The results were in line with expectations based on both screening animal studies the company conducted previously, and on published studies with other PFC blood substitutes. The test results will be used to support filing an investigational new drug application (IND) to secure FDA approval for clinical testing of Oxycyte in 1Q03. Robert Nicora, president and CEO, said the FDA had asked the company to conduct a special neurotoxicity study in rats using Oxycyte in the wake of last year's report of an increased occurrence of stroke in patients being treated in a Phase III clinical study conducted by another company with a competing PFC blood substitute. "The results of our study showed no pathological effects in the brain from Oxycyte administration," Nicora said. The company said it believes that Oxycyte has the potential of being a blockbuster drug that may be beneficial in surgery and organ preservation and in treating trauma, metastatic disease, heart attacks and strokes.

Thoratec (Pleasanton, California) said the Technology Evaluation Center (TEC) of the Blue Cross and Blue Shield Association has completed an assessment for use of left ventricular assist devices (LVADs) as destination therapy and determined that the use of LVADs as destination therapy for patients with end-stage heart failure who are not eligible for heart transplantation meets its five criteria, including that the technology improves net health outcomes. On Nov. 6, the FDA granted Thoratec approval to market its HeartMate SNAP-VE LVAS for destination therapy to provide permanent support for end-stage heart failure patients who are not eligible for heart transplants. Under the new indication, the HeartMate SNAP-VE can be used to support patients with New York Heart Association Class IV end-stage left ventricular failure who have received optimal medical therapy for at least 60 of the last 90 days, have a life expectancy of less than two years and are not candidates for cardiac transplantation. Thoratec's air-driven and electric HeartMate heart assist devices are implanted alongside the natural heart and take over the pumping function of the left ventricle for patients whose hearts are too damaged or diseased to produce adequate blood flow.

Vasomedical (Westbury, New York) received CE mark approval for its EECP enhanced external counterpulsation systems. That enables the company to begin marketing new or improved EECP products in all 15 EU countries and cooperating partner countries without undergoing separate review and inspection for each product. As a result, Vasomedical has begun marketing its Model TS3 EECP system, which includes its patent-pending congestive heart failure treatment and oxygen saturation monitoring technologies, throughout the EU.

WorldHeart (Ottawa, Ontario) said it has requested Health Canada approval to use an ePTFE inflow conduit as an alternative option for its Novacor LVAS (left ventricular assist system). The conduit has been approved for European use and is now under review by the FDA in the U.S. The inflow conduit carries blood from the natural heart to the Novacor LVAS, which then pumps the blood into the aorta to assist a failing heart. The conduit, developed by WorldHeart, utilizes expanded polytetrafluoroethylene (ePTFE) graft material. "We know that Canadian physicians have been eagerly waiting the availability of the ePTFE conduit, since it has decreased the possibility of complications from stroke to less than ten per cent in European use," said Tofy Mussivand, chairman and chief scientific officer of WorldHeart. "We expect sales for Novacor LVAS to approximately double over the next five quarters, reflecting expansion in active implant centers and anticipated approval of the ePTFE conduit in the U.S. and in Canada," added Rod Bryden, president and CEO.