Not every acquisition of a venture-backed biotech in 2009 was a structured deal that included earn-outs based on clinical or regulatory milestones. But it sure was close. Thirteen private biotechnology companies were acquired in 2009 and of those deals only a few did not include contingent value rights (CVRs). . . . [MORE . . .]

As public health officials warn about new strains of resistant bacteria spreading in hospitals, drug firms have been slow to produce new ammunition. But the past few years have seen a spate of deals, both licenses and acquisitions, among firms maneuvering into the antibiotic space. The latest antibiotic deal-AstraZeneca PLC's two-step, $350 million acquisition of Novexel SA--happened just before the winter holidays and was easy to overlook amid the year-end flurry of industry action. It's worth revisiting for a few reasons. . . . [MORE . . .]

Transoma, which was developing an implantable ECG monitor for continuous, wireless arrhythmia monitoring closed its doors in December. Before that, Medtronic failed to gain FDA approval for an implantable hemodynamic monitor for heart failure. That's two strikes; what will it take for companies with implants for wireless monitoring to stay in the game? Jay Yadav, MD, of CardioMEMS gives his opinion. . . . [MORE . . .]

For the manufacturers of computer-aided detection products, 2009 was not a good year. For the industry as a whole, revenues dropped 10%, according to "US Markets for Computer-Aided Diagnostic Imaging Products," a report recently issued by the Medtech Insight division of Elsevier Business Intelligence. This was largely due to the economic recession, cost pressures faced by hospitals, and a subsequent squeeze on capital equipment-related products. But for the foreseeable future, the industry is expected to grow at a compound annual rate of 11.1% to reach an estimated $185.3 million by the years 2013. . . . [MORE . . .]

Some of our favorite blog posts about topics not covered elsewhere in this issue of Start-Up. (See the original postings for free at http://invivoblog.blogspot.com/). . . . [MORE . . .]

New company creation slipped significantly in 2009 as venture capitalists conserved capital and supported existing portfolio companies. In biopharmaceuticals, corporate venture got in at the ground floor while device start-ups continued to see stronger support from smaller, regional investors than traditional VCs. . . . [MORE . . .]

Which kinds of innovations make for incremental enhancements in the hands of large companies and which are meaningful enough to sustain a venture-backed start-up company? In a mature market for coronary stents dominated by large companies, start-ups developing new stents need to find the answers. Areas of innovation fall into four basic categories: improving stent safety and biocompatibility, avoiding the need for dual antiplatelet therapy, enhancing deliverability, and introducing specialty stents for complex vessels. Three companies profiled here have a plan for taking sufficient market share, reducing risk, and rewarding investors. . . . [MORE . . .]

Regulatory risk and a mature market for some indications have driven Big Pharma players from the gastrointestinal space. That signals possible biotech opportunity. In this issue, we profile Alvine Pharmaceuticals, Genetic Analysis, Meritage Pharma and Ventrus Biosciences. . . . [MORE . . .]

Alvine Pharmaceuticals aims to treat celiac disease-a common hereditary autoimmune disorder in which the intestinal lining reacts to wheat, barley or rye gluten, leading to pain, bloating, and damage to the gut--with an orally available drug meant to degrade gluten in the stomach into peptide fragments too small to stimulate an immune response. Generally, antigens need to be at least nine amino acids long to rouse an immune response, but Alvine expects its lead compound to chop up gluten into peptide fragments a third that size or smaller. . . . [MORE . . .]

A number of diseases are associated with or influenced by imbalances in gut bacteria, including autism and GI disorders such as ulcers, Crohn's disease, inflammatory bowel disease, irritable bowel syndrome, colon cancer, and necrotizing enterocolitis in preterm infants. Many other conditions not obviously associated with the gastrointestinal tract also seem to be influenced by imbalance in the gut, such as allergies, eczema, depression and obesity. Genetic Analysis is developing the G-MAP, a microbiota array technology that analyzes and profiles the gut microflora and associates the resulting profile with various diseases. . . . [MORE . . .]

Meritage Pharma was built by serial biotech entrepreneur Cam Garner around a viscous formulation of budesonide designed to coat the inflamed throat. It is now in Phase II trials for an orphan indication, pediatric eosinophilic esophagitis, an inflammation of the esophagus that appears to be triggered by allergies. Meritage's decision to reformulate a compound with a well-established safety record is, like the choice to pursue an orphan drug designation, a risk- and cost-reducing maneuver that has helped other biotech companies achieve success. . . . [MORE . . .]

Like other start-up companies working to develop drugs for GI disorders, Ventrus Biosciences was attracted to the sector not only by unmet clinical needs and the focused sales opportunities, but also by the potential for creating a cross-over success: a drug that launches as a prescription product but eventually leaps over the counter to become a blockbuster, á la Claritin. Ventrus has two drug candidates ready for Phase III testing: a topical gel formulation of diltiazem, a generic vasodilator, as a treatment for anal fissures, and a novel compound it hopes will become the first new product approved for hemorrhoids in 30 years. . . . [MORE . . .]

For more than 20 years, cardiac ablation catheter development has focused on two major areas: three-dimensional mapping systems to determine a specific patient's heart dimensions to help map arrhythmias and guide catheters, and mechanisms for catheter positioning and steerability. Little attention has been devoted to ablation lesion success and safety assessment. Advanced Cardiac Therapeutics Inc. aims to fill this gap with its intelligent, in-tissue, temperature-sensing irrigated ablation catheter. The device features a chip-based radiometry system to provide physicians with real-time in-tissue temperature when performing irrigated cardiac ablations. . . . [MORE . . .]

Isolated from seawater, deuterium is a naturally occurring stable isotope of hydrogen that carries an additional neutron, and it is sometimes known as "heavy hydrogen." Concert Pharmaceuticals Inc. is using the properties of deuterium to create therapeutics based on existing drugs. Adding it to a compound can modify metabolism and create new applications and intellectual property, which Concert feels will enable it to develop highly differentiated medicines more quickly and at lower risk of failure. The company's lead candidate, the HIV protease inhibitor CTP-518, is a deuterium-modified version of Bristol-Myers Squibb's atazanavir. . . . [MORE . . .]

Although more than 20 million people in the US are affected by obstructive sleep apnea (OSA), the standard of care for the disorder--a continuous positive airway pressure (CPAP) machine applied at bedtime with a nasal or facial mask to keep airways propped open--carries a noncompliance rate of almost 50%. ImThera Medical Inc. is developing a new implantable neurostimulation device that stimulates certain tongue muscles during sleep to open the upper airway and potentially help patients who are unable or unwilling to use CPAP or pursue surgical alternatives. . . . [MORE . . .]

Formed by the 2009 merger of CELLective DX and DNA Repair Co., On-Q-ity Inc. is developing personalized molecular diagnostics for cancer. The start-up thinks that combining DNA repair biomarkers with its ability to capture and analyze circulating tumor cells provides a complete view of an individual patient's pending treatment options and allows for more patient-friendly monitoring of the treatment's progress. On-Q-ity is currently conducting large-scale trials analyzing the response of DNA repair mechanisms to breast cancer therapies, focusing particularly on the anthracycline class of drugs. Initial studies are based on tissue samples, but the company will begin trials with circulating tumor cells in various cancers later this year. . . . [MORE . . .]

Swiss-based Telormedix is developing small-molecule drugs for cancer and auto-immune disease, harnessing the innate immune system--and toll-like receptor 7 (TLR-7) in particular. . . . [MORE . . .]

Brief profiles of these recently formed companies: Lungpacer Medical, OtoKinetics, Thermalin Diabetes and Vortex Biotechnology. . . . [MORE . . .]

Imagine exposing a person to a particular wavelength of light and having a predetermined species of neuron shut down for as long as that light is on. Then a second light comes in to turn another neuron off, or turn one on, and so on. That's what an emerging group of researchers and a couple of start-up companies hope to be able to do, to potentially treat a variety of neurological conditions from chronic pain to seizures to spinal cord injury and even eye diseases. . . . [MORE . . .]

Recent executive-level hires and director appointments at venture capital firms and biopharma and medtech start-ups. . . . [MORE . . .]

Each month, Start-Up presents a comprehensive review of young, private life science companies that have received venture funding during the month, including companies in the pharmaceutical, medical device, diagnostic and research instrumentation & reagent sectors. . . . [MORE . . .]

Our monthly update on technology transfer deals--licensing agreements between companies and universities or other research institutions--in the fields of life sciences, including pharmaceuticals, medical devices, in vitro diagnostics and research/analytical instrumentation and reagents. . . . [MORE . . .]