Lawrence Livermore National Laboratory (LLNL; Livermore, California) has partnered with BioLuminate (San Jose, California) to develop Smart Probe, a tool for earlier, more accurate breast cancer detection that removes no tissue and is expected to achieve accuracy levels comparable to surgical biopsies in detecting cancerous cells.
The BioLuminate Smart Probe, smaller than the needle used in routine blood tests, is inserted into breast tissue after an initial screening indicates an area of concern. The probe looks for multiple known indicators of breast cancer, instantaneously providing physicians with information they can use to determine whether more invasive and costly tests are necessary. The results of the Smart Probe procedure are immediately available to patients, helping relieve anxiety.
Lawrence Livermore has signed a research and development agreement with BioLuminate to use the LLNL's optical imaging and probing technology to develop the device for all cancer detection applications. BioLuminate and Livermore researchers are designing and fabricating the first Smart Probe' prototype. The first human studies are expected to begin this spring at sites to be selected in Northern California. The device is expected to be commercially available by 2003.
"Physicians have been seeking a way to acquire more specific information about a suspected cancer site before performing a biopsy or surgery," said Neil Gorrin, MD, assistant chief of surgery at Kaiser Permanente Medical Center (South San Francisco, California). The Smart Probe not only is less invasive, but it provides several specific measurements of known cancer indicators in real time, which will improve our chances of making the right diagnosis and treatment plan for the patient."
Approximately 16,000 women undergo surgical breast biopsies in the U.S. each week on suspicious tissue that turn out to be benign, BioLuminate said. In addition, physicians miss about 4,600 cases of breast cancer each week during physical examinations and mammogram reviews.
"By using the Smart Probe before biopsies are performed on suspicious lesions, many unnecessary surgeries can be eliminated," said Richard Hular, president and CEO of BioLuminate.
Once a mammogram or physical exam has detected a possible malignant lump, Smart Probe is inserted into the tissue and guided to the suspicious region. Sensors on the tip of the probe measure specific optical, electrical and chemical properties known to differ between healthy and cancerous tissues. The Smart Probe can detect five to seven known indicators of breast cancer. Tissue measurements are made, in both normal and suspect tissue, in real time through a small, 20 gauge to 21 gauge disposable that is connected to a computer.
Smart Probe's sensors begin gathering information the moment the probe is inserted into tissue. Computer software compares the real-time measurements to a set of known, archived parameters that indicate the presence or absence of cancer. The results are displayed instantly on a computer screen.
"The technology and experience that Lawrence Livermore Lab has to offer will allow the Smart Probe to be much smaller than first conceived and acquire data more accurately," said Luiz Da Silva, PhD, Livermore's associate medical technology program leader and primary investigator for the Smart Probe. "In addition, we will have the capacity to add additional measurements if necessary."
Eventually, it is envisioned that the device will be used on prostate, lung, colon, cervical and brain cancer patients to detect malignancies and deliver and monitor treatment.
BioLuminate, a start-up firm, is developing the Smart Probe in collaboration with LLNL and the National Aeronautics and Space Administration's Ames Laboratory. Bioluminate is a relatively new company. It was formed in April 2000, and is in its second round of series B financing, hoping to raise $5 million in this round. According to Hula, the company has come up with an additional financing model in which corporate sponsors will help underwrite BioLuminate expenses. The company has an exclusive license to NASA's Smart Surgical Probe technology for all cancer applications and has the exclusive rights to develop LLNL's optical imaging and probing technology for all cancer detection applications.
Elsewhere in the product pipeline:
Advanced Magnetics (Cambridge, Massachusetts) has submitted a supplemental new drug application (sNDA) to the FDA for an expansion of the indications for Feridex I.V., as well as a more convenient, rapid-infusion dosing regimen. Feridex I.V. is the company's magnetic resonance imaging contrast agent that aids in the detection of liver lesions. The sNDA seeks approval for claims relating to the characterization of lesions as benign or metastatic. The company believes that sNDA approval could improve the product's position in the marketplace. Feridex is marketed in the U.S. by Berlex Laboratories, a subsidiary of Schering AG of Germany. The original NDA was approved on Aug. 30, 1996.
Advanced Neuromodulation Systems (ANS; Dallas, Texas) said it received FDA investigation device exemption approval to initiate a pilot clinical study of its proprietary Genesis Totally Implantable Pulse Generator (IPG) spinal cord stimulator for relief of chronic severe headaches (occipital headaches). The study of 10 patients at two sites in the U.S. is expected to begin in 1Q01. Data from the study, including pain medication reduction, quality-of-life information and Visual Analog Scale measures, will be used to determine the parameters for a larger pivotal study to support a premarket approval application for ANS' Genesis IPG for the occipital headache indication. ANS recently announced that it has received CE-mark approval for the Genesis IPG for the treatment of chronic pain of the trunk and limbs, and that it has completed initial patent implants of the device in Europe.
Applied Imaging (Santa Clara, California) has been issued a U.S. patent for the detection and simultaneous analysis of cells. This patent protects techniques developed by the company and available in its MDSsystem to detect targeted cells, such as cancer and fetal cells, and to analyze simultaneously the gene and protein expression in these cells using both bright field and fluorescence microscopy. According to the company, the use of bright field and fluorescence technologies together allows the analysis of cellular proteins while simultaneously determining which genes within that cell have been activated or expressed. Applied Imaging supplies the automated imaging systems used in genetics and pathology laboratories for the analysis of chromosomes in cancer and prenatal disorders.
Avitar (Canton, Massachusetts) has submitted a 510(k) premarket notification to the FDA to determine substantial equivalence of its ORALscreen 3 Test System, intended for qualitative detection of cannabinoids, cocaine and opiates drugs-of-abuse in oral fluid, to a previously marketed test system. "FDA clearance to market of our ORALscreen 3 Test System would provide us with the ability to sell our product in the regulated clinical diagnostics market, which represents approximately 10% of the $1.5 billion substance abuse testing marketplace," said Doug Scott, Avitar's president. The company's oral fluid technology samples saliva to detect trace amounts of illegal primary substances and metabolites in the body.
Boston Scientific (Natick, Massachusetts), in cooperation with PercuSurge (Sunnyvale, California), a division of Medtronic (Minneapolis, Minnesota), said it has enrolled its first patient in a clinical trial that deploys a carotid stent with a distal protection device, using Boston Scientific's Carotid Wallstent Monorail Endoprosthesis in conjunction with PercuSurge's Guardwire Plus Distal Protection System. The study will evaluate the potential of this minimally invasive alternative to open surgery for preventing stroke. The FDA has granted a conditional approval of the investigational device exemption for the SHELTER (Stenting of High-risk patients Extracranial Lesions Trial with Emboli Removal) trial. The trial is a single-arm, prospective, multicenter study that is scheduled to enroll about 400 patients at 30 sites. It is directed specifically to patients who are at high risk for complications associated with carotid endarterectomy, a traditional form of open surgery used to remove plaque from the carotid arteries. The trial uses the PercuSurge distal protection device designed to reduce complications that arise when particles of dislodged plaque or emboli travel through the bloodstream to the brain during surgery.
Bovie Medical (Melville, New York) said the FDA has approved its 510(k) application to market the Bovie 1250, a 120-watt powered generator for use in such areas as general surgery, gynecology, plastic surgery and other minimally invasive surgical procedures.
Cardiac Science (Irvine, California) has been awarded a U.S. patent for disposable defibrillation electrodes optimized to alleviate skin irritation and patient discomfort resulting from multi-day wear. The patent was originally applied for in 1997 by Cadent Medical, and was assigned to Cardiac Science in conjunction with its acquisition of Cadent in July 2000. The electrodes consist of miniaturized segments separated by open spaces, which the company says provide enhanced patient comfort and improved efficacy for long-term wear when compared with conventionally shaped defibrillation electrodes. It is anticipated that the patented electrodes will be used with Cardiac Science's Powerheart hospital bedside defibrillator-monitor and new products under development, including its Automatic Defibrillation Module designed for integration with standard patient monitoring systems and its Wearable Cardioverter Defibrillator. The company also said it has filed 12 additional patents over the past year related to its tachyarrhythmia detection, defibrillation and electrode technology platform and its various applications. Cardiac Science also has been granted approval by the Australian Therapeutic Goods Administration to allow Cardiac Science to begin marketing the Powerheart defibrillator-monitor in Australia.
CardioTech International (Woburn, Massachusetts) said it has started bench testing its CardioPass microporous coronary artery bypass graft. The CardioPass graft is made of ChronoFlex biodurable polyurethane, features three layers similar to natural arteries and is designed to replicate the biomechanical properties of human arteries. CardioTech said the CardioPass grafts are to be used in no-option patients whose saphenous veins have been used in previous surgical procedures.
Cerus (Concord, California) and Baxter Healthcare (Deerfield, Illinois) have submitted a CE-mark application for approval to market the Intercept Platelet System in Europe. The system, jointly developed by Cerus and Baxter Healthcare, is designed to inactivate viruses, bacteria, other pathogens and white blood cells in platelets intended for transfusion. If approved, the Intercept Platelet System will be the only system available to enhance the safety of platelet transfusions through pathogen inactivation, according to the company.
Conceptus (San Carlos, California) said that bilateral placement has been achieved in more than 400 patients in the pivotal clinical study of the STOP (Selective Tubal Occlusion Procedure) non-surgical permanent contraception device for women. The STOP device is a micro-coil designed to be deployed permanently into each fallopian tube using the company's minimally invasive transcervical tubal access catheter system. The study was designed to obtain 12-month effectiveness data on 400 patients with bilateral placement to support a premarket approval application. Accordingly, the PMA application filing timeline is expected to be accelerated by approximately three months. Enrollment in the STOP trial began in May 2000. The pivotal study protocol requires 12 months of follow-up after each patient begins to rely exclusively on STOP for contraception, which occurs three months after the placement procedure. The company is working toward a PMA filing with the FDA during 3Q02, with CE-mark approval in the near future.
CTI (Knoxville, Tennessee), a supplier of products and services for positron emission tomography (PET), said the Health Care Finance Administration has agreed to provide expanded coverage for PET diagnostic procedures in cancer, heart disease and neurological seizures. The new, expanded policy will provide broad coverage for the diagnosis, staging and restaging of lung cancers, colorectal cancers, lymphoma, melanoma, esophageal cancers and head and neck cancers. Additionally, the new policy will include FDG cardiac scans for the evaluation of myocardial viability and neurological scans for the presurgical evaluation of patients with epilepsy.
CYBeR-Care (Boynton Beach, Florida), a telehealth technology company, received FDA clearance to market its blood glucose monitoring system Glucometer. The Glucometer will be integrated with its Electronic HouseCall System family of products. All information is received in real-time by the caregiver and is available to payors and caregivers through the company's secure network. Caregivers can measure results against historical data from the Glucometer and other monitoring tools available on the Electronic HouseCall System, enabling them to deliver more effective care. The product underwent clinical trials at the Shepherd Center (Atlanta, Georgia), a specialty hospital, and product shipments were to begin in January.
Cyberonics (Houston, Texas) reported the start of the European D-03 clinical study of vagus nerve stimulation (VNS) for the treatment of depression at Beaumont Hospital (Dublin, Ireland) with implantation in a 48-year-old male patient, the first of 30 to be enrolled. The D-02 pivotal study of VNS for depression is under way at 20 U.S. sites. Cyberonics said that 102 patients have been enrolled, of which 66 have now been implanted with the NCP system. Total patient enrollment of that study is projected to be completed by mid-2001. VNS therapy is delivered by the Cyberonics NCP system, an implantable medical device similar to a cardiac pacemaker.
Cbyon (Palo Alto, California) said it has been issued a broad, enabling patent related to the company's surgical navigation technology, which is marketed as the Cbyon Savant software suite to hospitals and surgeons so they may see through internal structures and guide surgical instruments during surgery. U.S. patent No. 6,167,296, titled "Method for Volumetric Image Navigation," was issued to Stanford University (Stanford, California). Cbyon is the licensee of the patent from Stanford, including additional pending U.S. and foreign patent applications. The technology covered by the patent creates the basis for the Cbyon Image Enhanced Endoscopy module, which displays a virtual anatomic image that is both matched and synchronized with the same perspective of the actual endoscopic image. Initial 510(k)-cleared applications include neurosurgical, spine, and ear, nose and throat surgeries.
Criticare Systems (CSI; Milwaukee, Wisconsin) said that a key U.S. patent was issued to the company concerning the measurement of blood oxygen saturation. According to the company, the technology increases both the speed and accuracy of the measurement as well as addressing a wider range of patient conditions. The system can be used to monitor oxygenation levels that are typically difficult to detect and monitor, including fetal patients where extreme motion obstructs measurement and other patient conditions where signal transmission is compromised.
Endonetics (San Diego, California) has begun clinical trials on its Gatekeeper Reflux Repair System for the endoscopic treatment of gastroesophageal reflux disease (GERD). The objective of the initial phase of the study is to evaluate the safety and performance of the Gatekeeper system in patients diagnosed with GERD. The Gatekeeper system will enable the endocopist to perform an outpatient, nonsurgical, anti-reflux procedure in the endoscopy suite in 60 minutes or less. It is anticipated that the system also will reduce the treatment costs associated with lifelong drug therapies or surgical reflux repair. Endonetics said it plans to expand the number of clinical sites outside the U.S. and will be in a position to file for CE mark in 1H01. Endonetics makes two catheter-based, single-use systems, one diagnostic and one therapeutic, for the management of GERD.
Endovasc (Montgomery, Texas) said that its collaboration with Hermes BioSciences (South San Francisco, California) has successfully produced a timed-release nicotine liposome. Low dose levels of nicotine have demonstrated extraordinary results in stimulating growth of new blood vessels that produce a biological by-pass around blocked arteries and blood vessels, according to the company. Developed during the past year for its potential use in treatment of blood and oxygen starved ischemic tissues, this liposome provides a three- to four-day release of controlled levels of nicotine needed to initiate the angiogenic or new vessel growth cascade that stimulates the body's natural re-growth process.
Escalon Medical (Wayne, Pennsylvania) said it was granted FDA approval for its digital camera system for ophthalmologists, known as the CFA Digital Imaging System. The system will be marketed through Escalon Medical Imaging LLC, the company's joint venture with MegaVision (Santa Barbara, California). Ophthalmologists routinely use photography as a diagnostic tool to detect problems in the retinas of diabetic and elderly patients. The digital cameras produced by MegaVision offer high-resolution imaging that provides significant benefits over cameras that use conventional film, according to the company. These images can be viewed through a personal computer for analysis and then stored electronically.
Guidant (Indianapolis, Indiana) has filed an investigational device exemption application with the FDA for its Galileo Intravascular Radiotherapy System. Already approved in Europe, the Galileo System is designed to prevent the reoccurrence of blockages in coronary arteries. The Galileo system, which is automated and uses beta radiation, is a three-component system consisting of a centering catheter, source wire and source delivery unit. Following angioplasty, the physician advances a centering catheter through the artery until it reaches the treatment area. The source delivery unit automatically advances the source wire, containing the radioisotope phosphorus 32 (32P), through the centering catheter to the diseased coronary artery. An automatically calculated, precise dose of beta radiation is then delivered to that site for a predetermined period of time and the source wire is then automatically retracted back into the source delivery unit.
Hemosol (Toronto, Canada) said an investigational new drug application has been filed for a Phase I/II open label study of the safety and effectiveness of Hemolink in patients with non-small cell lung cancer who are experiencing chemotherapy associated with anemia. Hemolink will be evaluated in 18 adult patients. The trial is slated for completion by 4Q01.
In-Line Diagnostics (Boston, Massachusetts) said its Transcutaneous Access Flow (TQa) device, indicated for the transcutaneous estimation of access blood flow, received FDA 510(k) clearance. The TQa technology provides real-time determination of vascular access blood flow rate based on relative changes in hematocrit (red cell volume). The company said this technique eliminates the need for dialysis line reversal. The TQa product feature will complement In-Line Diagnostics' basic Crit-Line platform, a noninvasive, stand-alone blood monitoring system that uses photo-optical technology enabling the continuous real-time measurement of whole blood parameters such as hematocrit, percent change in blood volume and oxygen saturation.
Integrated Surgical Systems (ISS; Davis, California), a maker of medical robotics products, said that the first successful DigiMatch (pinless) Total Hip Replacement surgery with its RoboDoc Surgical Assistant System was performed by William Bargar, MD, at Sutter General Hospital (Sacramento, California). The system has been in use in Europe since September 1998. Two sites are scheduled to join Sutter Medical Center in clinical trials soon. The clinical study, requiring a total of 160 patients, is expected to take five months to complete. Following the multicenter trials, ISS anticipates obtaining FDA approval by the end of this year.
IsoTis NV (Bilthoven, the Netherlands) began clinical trials for orthopedic and maxillofacial applications for its living bone implants grown in culture. The company said the trials represent the first patients treated with autologous tissue-engineered bone.
Mentor (Santa Barbara, California) unveiled what it called an improved implantable prosthesis for the treatment of erectile dysfunction. The Alpha I prosthesis incorporates a patented valve designed to prevent spontaneous inflation, which sometimes occurs as a short-term, post-operative condition following implant surgery.
MicroMed Technology (Houston, Texas) has received approval from FDA to expand the U.S. MicroMed DeBakey Ventricular Assist Device (VAD) feasibility study from its initial site at Methodist Hospital (Houston, Texas) to three sites and 20 patients. At Methodist Hospital, six patients have been implanted with the device by lead investigator Dr. George Noon, cardiovascular surgeon and Baylor Professor of Surgery, with assistance from co-investigator Dr. Michael DeBakey, Baylor College of Medicine chancellor emeritus. Following internal approvals, the additional sites are expected to begin implantation of the MicroMed DeBakey VAD early this year. It is expected that this expanded feasibility study will provide MicroMed with enough information to begin a multicenter pivotal study, eventually leading to FDA approval to market the device. VADs are currently marketed only as a bridge to heart transplant, but MicroMed said VADs have the potential to be used as an alternative to heart transplant.
Micro Therapeutics (MTI; Irvine, California) has received approval from the Japanese Ministry of Health and Welfare to market its Rebar line of micro catheters in Japan. Rebar micro catheters, cleared by the FDA for distribution in the U.S. in January 2000, are over-the-wire micro catheters used in interventional vascular procedures for the delivery of therapeutic drugs or embolic materials, including MTI's Onyx, under study in the U.S. Rebar incorporates a next-generation reinforced braided design for added strength. The company's line includes the Rebar-027 for peripheral vascular applications, the Rebar-14 for use in neuro vascular applications and the Rebar-18, which may be used in both neuro and peripheral vascular procedures. The micro catheters will be distributed by Century Medical, MTI's distribution partner in Japan, which specializes in distribution of catheter-based, interventional products.
Millipore (Bedford, Massachusetts) has introduced the first products in its line of Montage Life Science Kits. Montage Genomics Kits, which include necessary reagents and disposable materials, provide DNA suitable for the most sensitive genetic research applications in about half the time of existing kits. The new kits – for plasmid miniprep and PCR cleanup – use simple protocols that eliminate lengthy bind-and -elute methods and centrifugation.
Optical Sensors (OSI; Minneapolis, Minnesota) has received FDA clearance to market the CapnoProbe sensor, a disposable probe intended to provide a measurement of sublingual CO2 for patient monitoring. OSI originally filed a 510(k) application in December 1998 for FDA clearance to market the CapnoProbe sensor as a Class II medical device. In October 2000, OSI reported that the FDA had recommended that OSI resubmit a new CapnoProbe sensor 510(k) application. OSI said this approval allows it to proceed with pursuit of a distribution partner for the CapnoProbe sensor and complete CapnoProbe's commercial configuration for sale into hospital markets.
Ortec International (New York) said the clinical data from its recently concluded pivotal clinical trial evaluating the use of its Composite Cultured Skin (CCS) for wound closure of split thickness skin donor site wounds in burn patients achieved statistical significance for its primary endpoint, time to 100% wound closure. CCS-treated sites also demonstrated significantly better cosmetic outcome at 3 months and 6 months following application than control sites. The data generated from this trial will serve to support a PMA application, which Ortec expected to file last month.
Orthologic (Tempe, Arizona) completed enrollment in a 90-patient Phase I/II trial of Chrysalin, a synthetically manufactured peptide shown in animal studies to accelerate fracture healing.
QRS Diagnostic (Plymouth, Minnesota) has released a new USB electrocardiograph monitor. The palm-size ECG device connects to the Universal Serial Bus (USB) port on Windows-based laptop and desktop computers to provide a method of performing real-time cardiac monitoring. The new USB version comes in 6-channel and 12-channel configurations, with the 6-channel version designed specifically for remote monitoring applications, telemedicine, and home disease management programs.
Spectranetics (Colorado Springs, Colorado) said that Luc Bilodeau, MD, of the Montreal Heart Institute (Montreal, Quebec), and David Hilton, MD, of the Royal Jubilee Hospital (Victoria, British Columbia), have completed a successful pilot evaluation of the use of higher laser energy delivered through the company's POINT 9mm catheters to open blockages in coronary arteries that were previously untreatable via laser angioplasty. The X80 Study involved 36 patients at the two Canadian hospitals who had high-grade lesions (i.e. greater than or equal to 80% blockages) with evidence of calcification, chronic total occlusions traversable by a guidewire or high-grade lesions that had previously failed balloon angioplasty.
St. Jude Medical (St. Paul, Minnesota) has received premarket approval from the FDA for the Micro AutoCapture Pacing System. At only 18 g and 8 cc, the Integrity Micro AutoCapture Pacing System is, according to the company, the world's smallest dual-chamber pacemaker – approximately 30% smaller than competitive dual-chamber offerings. In addition to its small size, the system includes an advanced feature set, built upon the Integrity AFx pacemaker platform. U.S. launch of the system was set for last month. The company also reported receiving PMA clearance from the FDA for its enhanced Model 3510 Programmer and associated programmer software, which supports the company's implantable cardioverter defibrillators (ICDs) and pacemakers, including the recently FDA-approved Photon DR dual-chamber ICD and the Integrity pacemaker family.