Pain management

Collegium to Host Conference Call to Discuss Third Quarter 2021 Financial Results and Provide Corporate Update

Thursday, October 21, 2021 - 9:01pm

The Company will discuss its financial results and provide a corporate update.

Key Points: 
  • The Company will discuss its financial results and provide a corporate update.
  • To access the conference call, please dial (877) 407-8037 (U.S.) or (201) 689-8037 (International) and reference the Collegium Pharmaceutical Q3 2021 Earnings Call.
  • The webcast will be available for replay on the Companys website approximately two hours after the event.
  • Collegium is a specialty pharmaceutical company committed to being the leader in responsible pain management.

DGAP-News: Tetra Bio-Pharma Receives Positive Opinion for Orphan Drug Designation for QIXLEEF(TM) from the European Medicines Agency

Thursday, October 21, 2021 - 12:09pm

An ODD brings several unique advantages, from a cost reduction in drug development, to an accelerated review process and market exclusivity for 10 years.

Key Points: 
  • An ODD brings several unique advantages, from a cost reduction in drug development, to an accelerated review process and market exclusivity for 10 years.
  • Such strategy is cost and time effective and allows the Company to easily gain market shares in a competitive free environment.
  • We firmly believe that QIXLEEF(TM) will be a safe and effective medicine for pain management and an alternative to opioids."
  • The positive opinion issued by the COMP will be sent to the European Commission, which is expected to grant the orphan designation within 30 days.

NeuroMetrix Reports Q3 2021 Financial Results

Thursday, October 21, 2021 - 12:00pm

WOBURN, Mass., Oct. 21, 2021 (GLOBE NEWSWIRE) -- NeuroMetrix, Inc. (Nasdaq: NURO) today reported financial and business highlights for the quarter ended September 30, 2021.

Key Points: 
  • WOBURN, Mass., Oct. 21, 2021 (GLOBE NEWSWIRE) -- NeuroMetrix, Inc. (Nasdaq: NURO) today reported financial and business highlights for the quarter ended September 30, 2021.
  • Q3 2021 revenue of $2.1 million exceeded revenue of Q3 2020 by $28 thousand.
  • The gross margin rate of 70.0% in Q3 2021 declined from 73.6% in Q3 2020 due to cost increases to secure electronic parts essential to the Companys products.
  • The Q3 2021 net loss of $687 thousand, or $0.12 per share, exceeded the net loss in Q3 2020 of $257 thousand, or $0.07 per share by $430 thousand.

Tetra Bio-Pharma Receives Positive Opinion for Orphan Drug Designation for QIXLEEF™ from the European Medicines Agency

Thursday, October 21, 2021 - 11:30am

Guy Chamberland, Chief Executive Officer and Chief Regulatory Officer of Tetra Bio-Pharma said "the positive opinion issued by the COMP is excellent news as Tetra continues to execute its regulatory strategy in Europe.

Key Points: 
  • Guy Chamberland, Chief Executive Officer and Chief Regulatory Officer of Tetra Bio-Pharma said "the positive opinion issued by the COMP is excellent news as Tetra continues to execute its regulatory strategy in Europe.
  • We firmly believe that QIXLEEF will be a safe and effective medicine for pain management and an alternative to opioids."
  • The positive opinion issued by the COMP will be sent to the European Commission, which is expected to grant the orphan designation within 30 days.
  • The COMP based on majority of 30 out of 31 votes concluded that QIXLEEF satisfies the criteria for such designation and recommends the granting of orphan medicinal product designation.

LG Announces Proto Challenge Winners

Wednesday, October 20, 2021 - 5:00pm

SANTA CLARA, Calif., Oct. 20, 2021 /PRNewswire/ -- LG Electronics has named the winners of the LG NOVA Proto Challenge, the preliminary startup competition that sets the stage for LG NOVA 'sglobal challenge program Mission for the Future .

Key Points: 
  • SANTA CLARA, Calif., Oct. 20, 2021 /PRNewswire/ -- LG Electronics has named the winners of the LG NOVA Proto Challenge, the preliminary startup competition that sets the stage for LG NOVA 'sglobal challenge program Mission for the Future .
  • "The LG NOVA Proto Challenge was designed to discover startups and entrepreneurs with new ideas and technology to create and grow new innovation with LG that offers real impact on society," said Dr. Sokwoo Rhee, senior vice president for innovation at LG Electronics and head of LG NOVA.
  • LG NOVA Proto Challenge winners were selected based on the following criteria: a clear vision to growing business with LG, a convincing pathway to commercialization, and the uniqueness of the proposed solution or product.
  • "Through the Proto Challenge, we've identified businesses that are meeting the challenge of building for the future," said Limor Schafman, director of strategy and operations at LG NOVA.

Nalu Medical kicks-off 'Engineered to be More™' with new product releases and software upgrade to provide more therapy options and support for its patients and physicians

Wednesday, October 20, 2021 - 4:00pm

The Nalu Neurostimulation System features a micro-Implantable Pulse Generator (mIPG) which is powered wirelessly by a wearable, external Nalu Therapy Disc.

Key Points: 
  • The Nalu Neurostimulation System features a micro-Implantable Pulse Generator (mIPG) which is powered wirelessly by a wearable, external Nalu Therapy Disc.
  • The external power source offers a distinct benefit over IPGs with implanted batteries, which require battery replacement surgeries over time.
  • Additionally, the Nalu software controlling the mIPG can be non-invasively upgraded so patients can benefit from future FDA-authorized therapy options and advancements without additional surgical interventions.
  • Nalu's Patient Care Portal allows for monitoring and addressing the needs of patients at each stage of their Nalu Neurostimulation experience.

AmMax Bio Announces Positive Interim Phase 2 Results of AMB-05X for the Treatment of Tenosynovial Giant Cell Tumor (TGCT)

Wednesday, October 20, 2021 - 1:00pm

REDWOOD CITY, Calif., Oct. 20, 2021 (GLOBE NEWSWIRE) -- AmMax Bio, Inc. (“AmMax”), a private clinical-stage biotech company developing novel treatments with AMB-05X, its proprietary anti-CSF1R monoclonal antibody platform, today announced positive interim data from a Phase 2 study of AMB-05X for the treatment of tenosynovial giant cell tumor (TGCT).

Key Points: 
  • We are very excited to report these positive interim results of AMB-05X for the treatment of TGCT, said Larry Hsu, Ph.D., Chief Executive Officer of AmMax Bio.
  • We are working closely with our investigators in Europe and the U.S. to complete our Phase 2 program and prepare for a pivotal trial.
  • As a locally-administered, non-surgical treatment, AMB-05X could offer an optimal balance of safety and efficacy as a meaningful treatment option.
  • AmMax is enrolling patients in Phase 2 clinical programs for tenosynovial giant cell tumor (TGCT) and has achieved nonclinical proof-of-concept in both neovascular age-related macular degeneration (nAMD) and idiopathic pulmonary fibrosis (IPF).

Knopp Biosciences NIH-funded Pain Program Advances to Third Year of HEAL Award to Discover Non-Opioid Treatments for Chronic Pain

Wednesday, October 20, 2021 - 11:00am

Knopp has developed a discovery platform of proprietary molecules directed to a non-opioid biological target linked to chronic pain caused by damage to nerves.

Key Points: 
  • Knopp has developed a discovery platform of proprietary molecules directed to a non-opioid biological target linked to chronic pain caused by damage to nerves.
  • Growing scientific evidence suggests that selectively activating key Kv7 channel subtypes can control nerve-cell hyperexcitability associated with transmission of chronic pain.
  • Receiving this next phase of HEAL funding, based on promising results in preclinical models of chronic and neuropathic pain, positions Knopp to advance our lead drug candidate into IND-enabling studies, said Michael Bozik, M.D., Chief Executive Officer of Knopp.
  • Knopp Biosciences is a privately held drug discovery and development company focused on delivering breakthrough treatments for immunological and neurological diseases of high unmet need.

FDA Clearance of an Expanded Indication for the SPRINT® PNS System Now Enables Treatment in Areas of the Head, Neck, and Torso

Tuesday, October 19, 2021 - 5:22pm

The clearance was based on real world safety data collected from over 5,500 patients using the SPRINT PNS System commercially, both on-label and off-label.

Key Points: 
  • The clearance was based on real world safety data collected from over 5,500 patients using the SPRINT PNS System commercially, both on-label and off-label.
  • The expanded indication allows access to the many millions of patients with certain types of head, neck and torso pain.
  • The SPRINT PNS System is not intended to treat pain in the region innervated by the cranial and facial nerves.
  • Our SPRINT PNS System fulfills a critical unmet need for a drug-free, surgery-free option for millions who suffer from chronic pain.

Clever Leaves Announces Partnership with Colombian-based Pharmalab PHL Laboratories to Provide Patients with Medical Cannabis

Tuesday, October 19, 2021 - 1:30pm

BOCA RATON, Fla., Oct. 19, 2021 (GLOBE NEWSWIRE) -- Clever Leaves Holdings Inc. (NASDAQ: CLVR, CLVRW) (Clever Leaves or the Company), a leading multinational operator and licensed producer of pharmaceutical-grade cannabinoids, announced the commercial commencement of a partnership with Pharmalab PHL Laboratories S.A.S (Pharmalab) in Colombia.

Key Points: 
  • BOCA RATON, Fla., Oct. 19, 2021 (GLOBE NEWSWIRE) -- Clever Leaves Holdings Inc. (NASDAQ: CLVR, CLVRW) (Clever Leaves or the Company), a leading multinational operator and licensed producer of pharmaceutical-grade cannabinoids, announced the commercial commencement of a partnership with Pharmalab PHL Laboratories S.A.S (Pharmalab) in Colombia.
  • Pursuant to the partnership, Clever Leaves will supply pharmaceutical-grade cannabinoid formulations to Pharmalab for the distribution of magistral medications in Colombia, which are used to treat painful and inflammatory pathologies.
  • Clever Leaves, as a large-scale supplier, with the collaboration of Pharmalab, will together contribute significantly to the commercialization of medicinal cannabis products within Colombia, concludes Andrs Fajardo.
  • Clever Leaves is a multinational cannabis company with an emphasis on ecologically sustainable, large-scale cultivation and pharmaceutical-grade cannabinoid processing as the cornerstones of its global cannabis business.