A prospectus was filed by New York City-based PAVmed for an offering of rights to buy up to 14.6 million units of common shares and Series Z warrants in hopes of raising almost $90 million. The proceeds will be used for research and development activities, as well to develop the company's existing pipeline.
A previously announced offering of 1% convertible senior notes due 2025 brought in $671.3 million in net proceeds for Exact Sciences, with the overallotment option fully exercised by underwriter Merrill Lynch, a filing with the SEC showed. The money will be used as working capital, as well as to support the company's general corporate functions.
Weight loss balloon maker Obalon Therapeutics announced plans to launch an offering of common stock in hopes of raising $35 million. The company also intends to grant underwriters an overallotment option to purchase an additional $5.25 million worth of shares.
Canadian firm CVR Medical and Chinese private equity firm Guangzhou LangRun Equity Investment Management signed a letter of intent to establish a joint venture for the commercialization in China of CVR's Carotid Stenotic Scan, which is designed for assessing carotid arterial health to predict ischemic stroke risk. Guangzhou LangRun, which will own 65% of the joint venture, will help fund it using capital from the LangRun Asset Fund, which it will set up to invest in senior care-focused and health care optimization-focused medical devices.
Israel-based Check-Cap has obtained CE mark approval from European regulators for its C-Scan System, which comes in the form of a pill that contains a positioning system, an X-ray source, a battery and computing components. The capsule, designed for colorectal cancer screening, provides viewing of the colon by shooting X-rays into the contrast agent swallowed by a patient, as well as through Compton scattering, and transmits imaging and location data to sensors worn by the patient.
A premarket authorization supplement was approved by the FDA extending the indications of Qiagen's Therascreen EGFR RGQ PCR kit, designed to aid in first-line treatment of metastatic non-small cell lung cancer that has EGFR mutations using Boehringer Ingelheim's Gilotrif, or afatinib. The approval is for the detection of G719X, L681Q and S7681 EGFR mutations.
Inspired by a zero-waste policy at her daughters' elementary school, Julie Corbett envisioned an environmentally friendly bottle comprising an outer shell of recycled paper and a thin, recycled plastic liner. A successful pilot test with a local dairy led to a client list including Seventh Generation and Nestle, and a new opportunity -- which Corbett almost missed -- with L'Oreal protege Seed Phytonutrients has taken her company, Ecologic Brands, to a new level of sustainability.
Stray dogs and cats shed Toxocara roundworm eggs when they defecate in yards, playgrounds and sandboxes, and children playing in those areas can inadvertently swallow the eggs, which hatch and release larvae into the body and possibly the brain. The CDC estimates that some 16 million people have been exposed to Toxocara, but studies show that pets that receive regular care from a veterinarian rarely carry the parasite.
The FDA granted Austin, Texas-based International Biophysics 510(k) clearance for its FloPump 32 centrifugal disposable heart pump, which is intended to be used with the RotaFlow console from Getinge subsidiary Maquet Cardiovascular. The device will be distributed solely by Origen Biomedical in the US and in Canada if approved by Health Canada next year.
The V-Go wearable insulin delivery system was introduced by Bridgewater, N.J.-based Valeritas in Puerto Rico. The product will be promoted to endocrinologists and general practitioners whose patients have type 2 diabetes through a partnership with Fusion Consulting Group, which will be in charge of sales activity; product development, manufacturing, regulatory approval and quality management will be handled by Valeritas.