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Home » New FDA rules imperil Bioject | Wall Street Beat

New FDA rules imperil Bioject | Wall Street Beat

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MassDevice.com Wall Street Beat

Bioject (OTC:BJCT) said it’s unsure of its ability to stay afloat after the FDA instituted new rules last year governing jet injection of vaccines, which accounts for about 70% of Bioject’s business, according to a regulatory filing.

In a filing detailing its inability to meet the deadline for its annual report, the Tigard, Ore.-based company said that although the new regulations were released in October 2011, a final FDA guidance isn’t expected until the 1st quarter of 2013.

"The new standard for use of jet injectors has imposed a significant additional financial burden on Bioject connected to testing of its devices with specific vaccine products," according to the filing. "Bioject is uncertain as to its ability to continue as a going concern."

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The new FDA regulations also forced the company to renegotiate some of its facility and manufacturing deals. To top it all off, there were "significant staff reductions" during the 4th quarter, according to the filing.

 Athersys CEO predicts MultiStem will be "biggest blockbuster"

Athersys (NSDQ:ATHX) CEO Gil Van Bokkelen predicts that the company’s MultiStem cell therapy for ischemic stroke "could easily" become the biggest biotech blockbuster. Read more

 Maquet, Siemens in hybrid OR pact

Siemens (NYSE:SI) and Getinge‘s (PINK:GETI B) Maquet subsidiary inked a deal to co-develop a so-called "hybrid OR," integrating Siemens’ imaging diagnostics technology into a Maquet surgical suite. Read more

 Barclays: FDA’s new PMA guidance a boon for investors

The new guidance on pre-market approval applications issued by the FDA could be a boon for investors interested in backing companies with upcoming FDA panel dates, including HeartWare International (NSDQ:HTWR), Boston Scientific (NYSE:BSX), St. Jude Medical (NYSE:STJ) and W.L. Gore, Edwards Lifesciences (NYSE:EW), Johnson & Johnson (NYSE:JNJ), Zimmer (NYSE:ZMH) and Stryker (NYSE:SYK).

 Avedro, ACOS partner on Phase III trial

Avedro and the American-European Congress of Ophthalmic Surgery are cooperating on a Phase III clinical trial of Avedro’s corneal collagen cross-linking technology for augmenting refractive surgery to treat keratoconus or corneal ectasia. Read more

 EnteroMedics, Optos tout first shipments

EnteroMedics and Optos each announced first-time shipments of their flagship products, Optos for the debut of its Daytona retinal imaging system and EneroMedics for the firstof its Maestro vagal blocking weight-loss device to ship Down Under. Read more

 Misonix inks government distribution deal

Misonix (NSDQ:MSON) inked a new government services partnership deal with Technical Communities to distribute its ultrasound devices to federal government institutions. Read more

 Hoya Vision buys Brazilian distributor

Hoya Corp.‘s (TYO:7741) vision care division acquired Optotal Hoya S.A., its exclusive distributor in Brazil. Read more

 GPOs: Mindray, Nihon Kohden ink HealthTrust deals

Mindray (NYSE:MR) and Nihon Kohden (TYO:6849) each inked deals with group purchasing organization HealthTrust for anesthesia and patient monitoring equipment, respectively. Read more

 Funding Roundp

 Analysts’ ups and downs

  • Allergan (NYSE:AGN): Lazard Capital downgrades from "buy" to "neutral."
  • Boston Scientific (NYSE:BSX): Credit Suisse maintains "outperform" rating, $7 price target.
  • Derma Sciences (NSDQ:DSCI): Oppenheimer lowers price target from $21 to $19, maintains "outperform" rating.
  • Endologix (NSDQ:ELGX): Lazard Capital downgrades from "buy" to "neutral."
  • Edwards Lifesciences (NYSE:EW): Brean Murray, Carret & Co. lowers EPS estimates, Sapien sales forecast, maintains "hold" rating.
  • Intuitive Surgical (NSDQ:ISRG): Lazard Capital downgrades from "buy" to "neutral."
  • Johnson & Johnson (NYSE:JNJ): TheStreet Ratings upgrades from "hold" to "buy."
  • St. Jude Medical (NYSE:STJ): Lazard Capital downgrades from "buy" to "neutral."
  • Teleflex (NYSE:TFX): Morgan Stanley "not as confident" in strategy as management, maintains "equal-weight" rating.
  • Zoll Medical (NSDQ:ZOLL): Lazard Capital downgrades from "buy" to "neutral."

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