Health Check: It’s child's play as Imricor shares surge on follow-up FDA clearance | Stockhead
Having won extended FDA clearance, Imricor can now use its MRI-guided ablation tools on kids both young and old. Pic: Getty ImagesImricor shares soar up to 16% after FDA paediatric clearance for its novel. . .
Having won extended FDA clearance, Imricor can now use its MRI-guided ablation tools on kids both young and old. Pic: Getty ImagesImricor shares soar up to 16% after FDA paediatric clearance for its novel ablation deviceBCAL acquires surprise stake in diagnosis peer Genetic SignaturesNo June swoon for these biotech heroesThe US Food & Drug Administration (FDA) has clearedImricor Medical Systems’ (ASX:IMR)diagnostic heart catheter and Northstar guidance system for paediatric use. Imricor’s interventional magnetic resonance (iMR) devices are the only ones compatible with magnetic resonance imaging (MRI). The clearance enables iMR-guided paediatric applications such as cardiac catheterisations, eliminating radiation exposure for the vulnerable little ones. “Children’s hospitals often have a strong interest in reducing radiation exposure and the use of contrast dyes for their patients,” the company says. “As a navigation system for use in iMR procedures, Northstar may be well suited to adapt and improve iMR procedure workflows currently performed with only stock MRI imaging system interfaces. ”The FDA approved Northstar and the catheter for adult use in January this year. “What has typically involved an MRI scan, followed by an X-ray lab intervention, can now be done in the iMR,” Imricor says. This delivers “significant time and cost savings to hospitals”. BCAL moves on Genetic SignaturesIn a “strategic” manoeuvre, breast cancer diagnostics developerBCAL Diagnostics (ASX:BDX)has moved to acquire a 10. 2% stake in struggling counterpartGenetic Signatures (ASX:GSS). BCAL today said it would expend $1. 39 million for 23. 1 million shares, at 6 cents apiece. BCAL noted that as a molecular diagnostics play, Genetic was “complementary”. Also, both companies have products in market and generate revenue. BCAL is commercialising its self-explanatory Breastest assay. An infectious diseases specialist, Genetic has developed an FDA-approved gastrointestinal parasite detection test called Easyscreen. On June 10 Genetic outlined the results of a 90-day strategic review, which in part found the company was trying to do too much. The company has “paused” its US Easyscreen rollout while it focuses on profitable growth. “Genetic Signatures gives BCAL exposure to an additional diagnostics pillar in infectious diseases, while supporting our broader strategy to build a stronger diagnostics platform across cancer and molecular testing,” BCAL co-founder and chair Jayne Shaw said. “We see many ways to work together for the benefit of both companies. ”This morning it was not immediately clear how BCAL would procure its Genetic stake – and whether the warm sentiment was mutual. Presumably the deal is friendly as life science companies don’t tend to ‘do’ hostile. Genetic shares today lost 0. 3 cents, or 4. 4% to 6. 8c. The stock has plunged 82% over the last 12 months, valuing the company at a very modest $14m. BCAL shares were unchanged at 7. 1 cents. Biotechs bounce in JuneWhile healthcare’s top stocks rallied in the month of June, less advanced biotechs and medtechs weren’t left behind, either. According toBiotech Daily, the top 40 biotech stocks climbed 11. 35%, for a collective market cap of $19. 6 billion. This measure excludes the Big Four ofCSL (ASX:CSL),ResMed (ASX:RMD),ProMedicus (ASX:PME)andCochlear (ASX:COH). These sector giants – albeit diminished ones – gained 16% in the month. For the year to June 30, the Top 40 lost 3. 3%, while the ASX/S&P200 index gained 2. 8%. Among the Top 40, ‘cannabis corner’ stocks came out smokin’. Avecho (ASX:AVE)shares soared 120%, after last week reporting positive interim results for its phase III synthetic cannabinoid insomnia trial. Little Green Pharma (ASX:LGP)shares spurted 85% after completing its merger with the unlisted Cannatrek. Shares in heart device playEBR Systems (ASX:EBR)jolted 43%. Then followed4D Medical (ASX:4DX)(36%),Neuren Pharmaceuticals (ASX:NEU)(29%),Telix Pharmaceuticals (ASX:TLX)(27%),Clinuvel Pharmaceuticals (ASX:CUV)(14%),ImpediMed (ASX:IPD)(12%),Dimerix (ASX:DXB)(10. 8%) andParadigm Biopharmaceuticals (ASX:PAR)(10. 3%). Neuren shares this week bolted after European regulators recommended approving its Rett syndrome drug, Daybu. Cynata Therapeutics (ASX:CYP)led the falls, down 95% after two negative stem cell trial results. Other big decliners wereCurveBeam AI (ASX:CVB)(48%),Adheris Health (ASX:AHE)(38%),Cyclopharm (ASX:CYC)(34%) andPolyNovo (ASX:PNV)(26%). But Cyclopharm shares today bounced 4% after the company reported first (June) half revenue of a record $17. 1 million, up 11%. This was on the back of the US rollout of the company’s Technegas imaging devices for pulmonary embolisms (PEs). However the company says the publication of expected international lung imaging guidelines has been delayed. These would have cemented Technegas as the “imaging agent of choice” for PE. As a result, Cyclopharm has pushed out its installation guidance of 250-300 Technegas systems from December 2026, into 2027. $80 million later, Chimeric ponders its optionsIn appointing a corporate adviser to review “strategic options”,Chimeric Therapeutics (ASX:CHM)says the $80 million expended to date on clinical work is “not currently reflected in the company’s market capitalisation”. You can say that again: Chimeric this morning was worth $2. 83 million – 87% less than a year ago. The company and its advisers, Hawkesbury Partners, will mull options including partnerships, licensing arrangements, co-development agreements, mergers, asset sale transactions and “alternative capital structures”. So everything is on the table, but there’s no guarantee of anything happening. Chimeric’s diverse oncology portfolio spans four active programs, covering autologous CAR-T therapies and allogeneic ‘natural killer’ curatives. But it all requires dosh. At the end of March Chimeric had slender cash of $1. 75 million, but with $2. 1m due from a placement. Alogorae clarifies “milestone” deal – sort ofAlgorae Pharmaceuticals’ (ASX:1AI)hospital supply contract with NSW Health highlights the frequent tension between the need for client confidentiality and continuous disclosure to the ASX. The company yesterday said the deal resulted from a public tender and covered three years with two one-year optional extensions. Mangement dubs the win as a “major milestone” and “strong validation” of its prospects. Great news! But the contract terms, “including pricing and volumes are confidential under the agreement. ”Today, the company at least confirmed the announcement pertained to a “pharmaceutical product”. Algorae is into AI-assisted drug discovery, but also has a commercial generics and specialty drug arm, AlogoraeRx. “Onboarding and rollout are underway, with first supply under purchase orders expected in [the December quarter],” Algorae said. The company also said it was one of several suppliers that NSW Health appointed. Algorae shares yesterday gained two cents, or 18% and were unchanged today. At Stockhead, we tell it as it is. While EBR and Dimerix are Stockhead advertisers, they did not sponsor this article.