FormCap Corp (FRMC): Yup....... Well I'm going hold , no way...

MADDSTACKER · 2017-06-09T13:56:42.3970000Z

Yup....... Well I'm going hold , no way to thin to sell... If no Rs easy 5 banger ....

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Proactive - Interviews for investors

Candel Therapeutics shares positive survival data for investigational immunotherapy in NSCLC

Candel Therapeutics CEO Dr. Paul Peter Tak joined Steve Darling from Proactive to announce final survival data from a Phase 2a clinical trial evaluating the company’s investigational immunotherapy in patients with stage III/IV non-small cell lung cancer (NSCLC) who had an inadequate response to immune checkpoint inhibitor (ICI) treatment. The study reported a median overall survival (mOS) of 24.5 months in 46 evaluable patients who received two courses of the investigational therapy. In a subset of patients who had progressive disease at baseline despite ICI treatment, mOS was 21.5 months. Historically, similar patients receiving standard-of-care chemotherapy have had mOS between 9.8 and 11.8 months, with published studies rarely exceeding 12 months. With a median follow-up of 32.4 months, the data demonstrated long-term survival benefits, with 37% of patients who had progressive disease despite ICI therapy still alive two years after treatment. Based on these positive results, Candel Therapeutics will continue advancing the development program, including preparations for a potential registrational trial in patients with non-squamous histology NSCLC. The U.S. Food and Drug Administration (FDA) has previously granted Fast Track Designation for the investigational therapy in combination with an antiviral agent and ICI therapy for patients with stage III/IV NSCLC who are resistant to first-line PD-(L)1 inhibitors and do not have activating molecular driver mutations or have progressed on targeted therapy. These findings support the therapy’s potential as a new treatment option for NSCLC patients with limited alternatives. #proactiveinvestors #candeltherapeuticsinc #nasdaq #cadl #CancerTreatment #ViralTherapy #ProstateCancer #PancreaticCancer #Glioblastoma #PaulPeterTak #ClinicalTrials #BiotechNews #Immunotherapy #Oncology #CancerResearch

Proactive - Interviews for investors

SomnoMed lifts revenue 19% amid soaring demand

SomnoMed CO-CEOs Amrita Blickstead and Karen Borg talked with Proactive about the company’s performance and opportunities in the global sleep apnea treatment market. The company, which develops proprietary oral appliances for obstructive sleep apnea, is seeing significant demand as patients seek alternatives to traditional CPAP therapy. “About 60% of people fail to be able to use actual CPAP therapy because it’s quite invasive,” Borg explained. SomnoMed’s devices offer a less intrusive solution and are distributed through dental channels in 28 countries, with strong uptake in the United States and Western Europe. The co-CEOs discussed a major tailwind from the rising use of GLP-1 therapies for weight loss, which is pushing more patients to explore alternative sleep apnea treatments. Increased public awareness of sleep wellness through apps and consumer health trends is also fueling demand. To meet this growth, Blickstead said their immediate focus was on ensuring “the right foundation for profitable growth.” This included strengthening the company’s financial base, reducing costs, paying down debt, and investing heavily in manufacturing. Production capacity has increased by over 40%, with revenue up 19% year-on-year and EBITDA for the first half reaching AUD 5.80 million, compared to a AUD 1.10 million loss previously. Despite these gains, Blickstead noted they are still “chasing our tails and trying to make enough product to continue to grow this business.” #SomnoMed #SleepApnea #OralAppliance #HealthcareInnovation #CPAPAlternative #GLP1 #SleepTech #MedicalDevices #HealthInvesting #ProactiveInvestors

Proactive - Interviews for investors

Structural Monitoring Systems: 20% growth & cash flow milestone

Structural Monitoring Systems Executive Chairman and CEO Ross Love talked with Proactive about the company’s aviation-focused growth strategy, recent product developments, and financial performance. Love explained that the company operates across three segments: avionics for special mission fleets, contract manufacturing, and the development of CVM (Comparative Vacuum Monitoring) technology for detecting microscopic cracks in metal structures. He noted, “The investment case is this is a business that will grow at around about 20% a year plus or minus.” One of the highlights discussed was the launch of a compact version of their digital audio system, which is tailored for emergency services and aerial firefighting fleets. These products are increasingly in demand, with installations underway across North America, including for California’s CAL FIRE — the largest aerial firefighting fleet. Love also detailed their expansion into South America, which is facilitated by similar infrastructure to the North American market. He said, “We supply most of the critical flights across North America… we’re making inroads into Europe and into South America.” On the financial front, Love highlighted that the company has doubled in size over the last two and a half years and is now operating with positive cash flow for the first time, following a successful capital raise of over $8 million. The company expects its first commercial revenues from CVM technology in the first quarter of the next financial year. #StructuralMonitoringSystems #AviationTechnology #CVMTechnology #AerialFirefighting #EmergencyServices #AerospaceInnovation #PositiveCashFlow #ASXSMN #AviationGrowth #DigitalAudioSystem #SouthAmericaExpansion

Proactive - Interviews for investors

EBR Systems nears FDA approval for CRT pacemaker

EBR Systems Inc Senior Vice President Andrew Shute talked with Proactive at the AIM maSmall and Midcap Conference about the company’s upcoming FDA decision for its leadless CRT pacemaker system. The device is designed to treat heart failure and represents the only leadless option in a market currently dominated by three players—with no direct competitor. Shute said, “We've developed the world's only leadless pacemaker to treat heart failure. And we're on track to receive FDA approval within the next two and a half weeks.”* The product already holds FDA Breakthrough Device designation, and has shown strong clinical results, including a 16.4% reduction in left ventricular end systolic volume—well above the target goal of 9.3%. Shute outlined the company's go-to-market plan, emphasizing that reimbursement is expected to begin from October 1st under the NTAP and TPT schemes, enabling an ASP of USD 45,000. The company only needs to sell around 2,200 units annually to reach USD 100 million in revenue. “We’ve got no direct competition,” he said. He also highlighted the successful completion of the FDA’s pre-approval inspection with no observations—an uncommon achievement in the medical device industry. The device, supported by data published in JAMA Cardiology, was also featured at the Heart Rhythm Society meeting in 2023. During the interim, the US commercial team will establish purchasing agreements, prepare technology committee engagements, and begin physician training for a limited market release. #EBRSystems #MedicalDevices #HeartFailureTreatment #LeadlessPacemaker #CardiacTech #FDAApproval #CRTDevice #InvestingInHealthcare #BreakthroughDevice #MedTechInnovation #JAMACardiology #HeartRhythmSociety

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