In what it termed a "significant milestone," Northfield Laboratories (Evanston, Illinois) said last month it is pinning hopes on a first-ever protocol approval from the FDA for its oxygen-carrying product PolyHeme. PolyHeme, essentially a blood substitute, has been tested in the trauma care area of an inpatient hospital setting, but the company is hoping for a second, broader indication: To be used in trauma before patients reach the hospital. If approved, it would be the first human clinical trial to evaluate the use of a blood substitute as the "initial resuscitative fluid" in the pre-hospital setting, according to the company.

To bolster the trial's chances, Northfield will conduct two trials simultaneously: a pre-hospital clinical trial for civilians and a non-randomized trial with the U.S. Army.

"The Army is not interested in a randomized trial," said Steven Gould, MD, chairman and CEO of Northfield. "They truly believe PolyHeme should be made available to their soldiers. Patients, or soldiers, will receive the product and data will be collected, but it won't be pivotal trial data. It would support the civilian trial and will support the data from the civilian trial," he told The BBI Newsletter. "The Army wants a blood substitute, and they have made it clear to us that they want it now," he added.

The announcement of the dual-trial approach is part of an effort by the company to better inform its stockholders concerning product development, Gould said. "One of the items we promised our stockholders at the annual meeting was a concerted effort to establish better communications," he said. "We recently hired an investor relations director, and had our first conference call on earnings. This is just one more way to communicate with our stockholders."

The multicenter, randomized, controlled, prospective study will evaluate the safety and efficacy of PolyHeme in reducing death in critically injured or bleeding patients. The product would be used during the initial rescue and during transport to a trauma center where blood is readily available. Although specifics are still being worked out, the trial will likely involve a number of sites and involve several hundred patients, Gould said. "Our early estimate is that it will cost between $10,000 and $15,000 per patient, but we haven't gotten a final number for that yet.

"From the outset, we believed that PolyHeme's most important clinical benefit would be to improve trauma care beginning at the scene of the injury, in both the military and civilian settings," he said. "The emergency medical technicians are well-equipped and trained to conduct this trial. That's why we think it's possible to do this trial. Patients would be randomized by hanging a bag of salt water or hanging a bag of PolyHeme in transit. But the difference is that, for the first time, an oxygen-carrier will be infused in the field rather than just saline," he explained.

Submitted as a special protocol assessment, the protocol request means both the company and the FDA acknowledge that successful completion of the trial will form the basis of the product's approval. "This is not a routine event at the FDA," Gould said. "By the agency allowing a special protocol assessment — which has only been allowed in the double-digits — it indicates the agency's support of the development of a product."

Northfield also is requesting that its product receive fast-track designation, thus allowing the company to submit certain portions of its biologics license application before the clinical trial is completed.

Along with trying to provide more information about product development, Gould is pursuing another goal that had been aggressively pushed by dissident shareholder C. Robert Coates. That goal is a partnership with a pharmaceutical company to increase the visibility of its blood substitute. "That's one of the promises we made at the stockholders meeting, and the other was to raise capital," Gould said. On that front, "we've been speaking with analysts and investment brokers to raise the profile of the company."

Elsewhere in the product pipeline:

Applied Digital Solutions (Palm Beach, Florida) reported that the FDA has notified the company that its VeriChip product is not a regulated medical device "for security, financial and personal identification/safety applications." The agency specified in its ruling that VeriChip is a regulated medical device for health information applications "when marketed to provide information to assist in the diagnosis or treatment of injury or illness." VeriChip is a miniaturized radio frequency identification device. The verification number is captured by briefly passing a proprietary scanner over the VeriChip. About the size of a grain of rice, each VeriChip product contains a unique verification number.

Bacchus Vascular (Santa Clara, California) reported the first U.S. use of its Fino Thrombectomy Catheter at the Jobst Vascular Center of the Toledo Hospital (Toledo, Ohio). The Fino Catheter successfully removed residual chronic and acute thrombus from the central and peripheral veins in a 41-year-old male following three days of catheter-directed thrombolysis. Bacchus said treating physicians requested the device's emergency use as they believed it represented the best means for thrombus removal in this specific patient. The Fino catheter is the subject of a clinical study in the U.S. for treating deep venous thrombosis. The system allows a physician to quickly remove a venous blood clot (thrombus) from the vein. By removing the clot, blood flow is restored within the vein to allow the venous valves to be returned to normal function.

Cardiac Science (Irvine, California) received FDA 510(k) clearance for an advanced version of its monitoring-defibrillation-pacing electrode pads. The new electrode pads are the disposable element of the company's fully automatic therapeutic bedside monitor, the Powerheart Cardiac Rhythm Module, which provides vigilant monitoring for hospitalized cardiac patients and can deliver therapeutic electric defibrillation shocks without human intervention. The Powerheart CRM electrode pads continuously sense patient heart rhythms and deliver defibrillation, when necessary. Smaller than their predecessors, the pads are designed for 24-hour patient wear and designed to fit a wide range of patient body shapes. Advanced ECG noise-reduction technologies are employed to filter artifacts caused by patient movement during monitoring to enhance arrhythmia detection.

Endologix (Irvine, California) reported favorable preliminary clinical results from a Phase II pivotal trial using its PowerLink System, an endoluminal stent graft for the treatment of abdominal aortic aneurysms (AAA). The results were presented by Dr. Jeffrey Carpenter, professor of surgery at the University of Pennsylvania (Philadelphia, Pennsylvania), at the late-September Transcatheter Cardiovascular Therapeutics conference in Washington. Based on the preliminary results from the pivotal trial, Carpenter concluded that the PowerLink System appears safe, while providing protection from aortic ruptures with few complications and no material flaws. The PowerLink System was successfully deployed in 115 patients without device-related, perioperative mortality. On average, patients were hospitalized less than three days and about one-quarter were treated using local or epidural anesthetic, foregoing the need for general anesthesia.

Guidant (Indianapolis, Indiana) received FDA approval under a humanitarian device exemption for its Neurolink system designed to treat atherosclerosis of the intracranial arteries, the vessels that distribute blood through the brain. Under the HDE approval, patients with recurrent stroke due to intracranial atherosclerosis who have failed medical therapy may be treated with the Neurolink system. The system, the only device of its kind approved for use in the U.S., consists of a balloon-expandable stainless steel stent with delivery catheter and a balloon dilatation catheter. Approval was granted following FDA review of data from Guidant's SSYLVIA (Stenting in SYmptomatic atherosclerotic Lesions of Vertebral and Intracranial Arteries) trial, a non-randomized, prospective safety and feasibility study that enrolled 61 patients with neurovascular atherosclerosis. The study was conducted at five centers in the U.S. and four centers in Europe. Clinicians reported the system demonstrated a degree of flexibility necessary to access difficult-to-reach atherosclerosis in cerebral vessels.

Harbinger Medical (Eden Prairie, Minnesota) said that the FDA cleared its Micro-Induction 1000 System, a high-fidelity, active-variance electrocardiograph intended for use in stratifying the risk of cardiac disease patients. In clinical studies at the University of Minnesota (St. Paul, Minnesota), the Mayo Clinic (Rochester, Minnesota) and Trondheim Regional Hospital (Trondheim, Norway), the measurements and analyses performed by the Harbinger System assisted in the risk stratification of post-myocardial infarction (MI) patients. Harbinger Medical Chairman and CEO, Byron Gilman said, "This milestone opens the next stage for us in moving from the final stages of development to the early growth stage." Harbinger was founded in 1993 to commercialize an improved, non- invasive diagnostic screening device for ventricular arrhythmias.

HydroCision (Andover, Massachusetts) was issued a medical device license from Health Canada for the VersaJet Hydrosurgery System for wound debridement and general surgery. The regulatory clearance followed prior FDA 510(k) clearance and CE mark certification. The VersaJet Hydrosurgery System enables surgeons to simultaneously hold, cut and remove damaged tissue and contaminants without the collateral trauma associated with current surgical modalities. The company said that with this device, debridement of traumatic wounds, chronic wounds and other soft tissue lesions can now be achieved in a single step, with a single instrument, and single-handedly.

Inamed (Santa Barbara, California) received FDA approval for its smooth round Style 68 High Profile and Style 68 Low Profile saline-filled breast implants. The additional two implant styles, along with the current Style 68 Moderate Profile implant, rounds out the McGhan Style 68 Saline Matrix family of products. Traditional planning relies on a combination of implant diameter and volume, with wider diameter needed for more projection. The Style 68 Saline Matrix family allows selection from three projections with the same base diameter.

Karl Storz Endoscopy-America (Culver City, California) launched Aida DVD at last month's annual meeting of the American College of Surgeons (Chicago, Illinois) in San Francisco, California. Aida DVD is designed to offer integrated image management in today's high-technology operating room. ACS attendees had the opportunity to experience what the company called Aida DVD's "advanced capabilities" first-hand, including digital image capture and real-time recording of streaming video to DVD. Aida DVD is designed to capture publishing-quality images. Surgeons also can record streaming video in the MPEG 2 format.

Kawasumi Laboratories America (Tampa, Florida) received FDA 510(k) clearance to market a needle safety device to protect oncology clinicians from Huber needle stick injuries incurred while removing needles from subcutaneous ports. The company said the Occupational Safety and Health Administration estimates that 600,000 to 800,000 healthcare workers are injured each year from needlestick injuries, and that many are exposed to blood-borne diseases such as hepatitis and HIV/AIDS. Kawasumi America's new plastic protection device, known as K-Shield, is designed to offer oncology nurses and staff protection from needlesticks and a convenient means for disposing of the Huber needle after removal from patients.

Lifecor (Pittsburgh, Pennsylvania) received PMA clearance from the FDA for its third-generation LifeVest defibrillator. FDA approval of the second generation LifeVest was granted in December 2001 after conclusion of a three-year, multi-center clinical trial. The LifeVest is a wearable defibrillator that can be worn outside the body rather than implanted in the chest, continuously monitoring the patient's heart to detect life-threatening abnormal heart rhythms. The new LifeVest has a biphasic defibrillation waveform enabling the monitor and electrode belt to be smaller, lighter, and more comfortable, the company said. The LifeVest's external defibrillator weighs only 1.7 lbs, compared to the second-generation device weighing 3 pounds.

Lumenis (Yokneam, Israel) has received marketing clearance from the FDA for the ReLume Repigmentation Phototherapy System for the treatment of leukoderma, or the loss of skin pigmentation. For stretch marks, acne scars, post-surgical and traumatic scars, burns and laser-resurfaced or chemically peeled skin, lost pigment now can be restored with the ReLume system, the company said. It was launched at last month's American Society of Dermatologic Surgeons meeting in Chicago, Illinois.

Medtronic (Minneapolis, Minnesota) has commercially launched the InSync Marquis system in Europe. The device also was launched in Canada for heart failure. This is the company's fourth-generation heart failure device and its second to treat patients who also need the protection of an implantable defibrillator. The Medtronic InSync Marquis, like the InSync ICD, provides cardiac resynchronization therapy (CRT) plus advanced defibrillation capabilities for patients at risk of potentially lethal tachyarrhythmias that may lead to sudden cardiac arrest. Based on the Marquis DR platform, the InSync Marquis is 38 cc in size — the smallest on the market — with 30 joules of delivered energy, and charge times of less than 7.5 seconds throughout the service life of the device. The InSync Marquis device combines the cardiac resynchronization therapy of the InSync ICD, the heart failure diagnostics of InSync III and all the features of the Marquis DR implantable cardioverter-defibrillator. Medtronic also said it is releasing in North America and Europe a percutaneously implanted lead for its InterStim Therapy for Urinary Control, which uses an implanted medical device akin to a cardiac pacemaker to stimulate the sacral nerves and improve bladder function. The new lead features tines, which eliminate the need for suturing and help keep the lead in place. It also may shorten the time required for implant and facilitate faster patient recovery as a result of less muscle trauma and a minimized surgical incision. Other features of the tined lead include visual, tactile and fluoroscopic markers that aid in proper placement. The simplified implant procedure can now be performed with only local anesthesia. Clinicians have reported no lead migrations. The tined lead received CE mark approval in April and FDA approval in September.

Mentor (Santa Barbara, California) received FDA approval for the Isoloader prostate brachytherapy workstation, designed to provide a safe and efficient way to flexibly load pre-sterilized radioactive seeds and bio-absorbable spacers into surgical needles while performing real-time radiation strength verification for each seed. During prostate brachytherapy, a minimally invasive treatment for prostate cancer, small radioactive sources, or seeds, are inserted into the prostate gland to kill the cancer cells. Mentor's system is designed to offer advantages to practitioners performing brachytherapy procedures, such as greater planning flexibility, improved radiation safety, improved control and better documentation, as well as time saving for each procedure. Mentor called the Isoloader system the first solid-state device cleared by the FDA for use as a dose calibrator in prostate brachytherapy.

Meridian Medical Technologies (Columbia, Maryland) said the U.S. Army received FDA approval for its highly automated assembly and filling production line for the Antidote Treatment Nerve Agent Auto-injector (ATNAA). The Army originally received FDA approval for its new drug application for the ATNAA in January. The company said it expects to begin manufacturing the ATNAA in January 2003. Meridian said the ATNAA, which uses the company's multi-chambered auto-injector technology, represents "significant advancements over the auto-injectors currently used by U.S. military."

Merit Medical Systems (South Jordan, Utah), a maker of disposable products used in cardiology and radiology procedures, received FDA clearance to market its new safety needle, the Majestik Shielded Needle. The company said the potential market for the new needle is approximately 10 million angiography procedures each year worldwide. Angiography needles are used specifically for vascular access, usually to a patient's femoral artery during a diagnostic or therapeutic procedure. The hollow needle provides an opening through which other devices such as guide wires can be placed. Merit's needle design involves a one-piece molded part that folds down over the needle tip following removal, thereby helping to minimize inadvertent needle sticks.

OmniSonics Medical Technologies (Wilmington, Massachusetts) said it received an investigational device exemption from the FDA to commence a U.S. clinical trial of its Resolution System for the treatment of thrombosed synthetic hemodialysis grafts. The company is developing a series of products to treat vascularocclusive disease based on its OmniWave technology. The prospective, multi-center clinical trial will target thrombosed synthetic dialysis access grafts to demonstrate safety and efficacy in rapidly clearing grafts.

Philips Radiation Oncology Systems (Cleveland, Ohio), a Philips Medical Systems business, has introduced AcQSim MR, a new software package that uses magnetic resonance imaging (MRI) to plan radiation treatment for oncology patients, and the Panorama 0.23T R/T, a new MR system dedicated to radiation therapy planning. The company said the MRI-based solution is the first of its kind and will enable clinicians to more accurately direct treatment to the diseased area and reduce irradiation of healthy tissue. Philips said the ability to use MRI for treatment planning is especially beneficial for patients with prostate, brain, head/neck, spine, and soft tissue sarcomas of the extremities. These cancer types account for from 30% to 35% of all treated cases with radiation. Philips Radiation Oncology said boundaries of soft tissue tumors are difficult to discern but that MRI is "ideally suited" for imaging organs such as the brain and prostate because of its distinctive ability to visualize soft tissue. It said that by using MR images where the tumor is imbedded in soft tissue, clinicians are able to more clearly define the tumor boundaries and prescribe a treatment plan that is much more precise to the diseased area.

RITA Medical Systems (Mountain View, California) received FDA 510(k) clearance to market its radiofrequency (RF) ablation technology to provide cancer patients with relief from the pain due to metastasis to the bone. The FDA clearance follows a clinical study of the effectiveness of RITA's RF system for the relief of pain from bone tumors conducted in the U. S. and Europe and presented at the annual meeting of the American Society of Clinical Oncology. The study, led by a team of physicians at the Mayo Clinic, showed that 95% of the patients treated with the RITA RF procedure experienced a significant reduction in pain from bone tumors. Of the 43 patients in the study, 41 experienced a significant reduction in the severity of their pain after a single treatment. The majority of the 41 patients reported significant pain relief within the first week after their treatment and said the relief increased in subsequent weeks. The company said it expects a limited introduction of the product by the end of 2002, followed by a more comprehensive launch in the first quarter of next year. While the current emphasis is on liver cancer and metastatic bone cancer, RITA said it believes that its technology could be applied to other types of tumors.

Scion Cardio-Vascular (Miami, Florida) received CE marking for its Sci-Pro filter protection device. The Sci-Pro is a guidewire-based filter and retrieval system designed to provide protection during interventional surgical procedures such as peripheral circulatory percutaneous transluminal angioplasty and stenting. The device is designed to provide distal protection, while serving as an embolic material retriever. The product uses a push/pull system to open and close a nitinol basket and requires no delivery sheath.

Synovis Surgical Innovations (St. Paul, Minnesota), a division of Synovis Life Technologies, received approval to market its Veritas Collagen Matrix, a remodelable biomaterial product, in Canada. The approval covers the use of Veritas as an implantable material for three applications: pelvic floor reconstruction, pelvic organ prolapse repair and as a sling for the treatment of stress urinary incontinence (SUI), all common conditions in post-menopausal women. Clinical results from studies under way at five U.S. medical centers indicate Veritas is efficacious in these applications, with no infections, no rejections and no erosion of the implanted tissue.

Varian Medical Systems (Palo Alto, California) has received FDA 510(k) clearance for Acuity, a new medical imaging product that integrates planning, simulation, and verification software for treating cancer with radiation therapy. The new product is intended to accelerate adoption of intensity modulated radiation therapy (IMRT), a technique for treating cancer. It is designed to support radiotherapy by tracking tumor motion during the simulation and verification process. The Acuity product can free the linear accelerator to be used exclusively for treatment delivery. The new product is tightly integrated with Varian's VARiS Vision data management system and with Eclipse treatment planning to streamline radiation oncology department workflow. It also works with radiotherapy products from many other vendors through an open architecture design and utilization of the DICOM RT standard.