Healthcare Innovators: Catheter Precision Expands in UK, LIXTE Gains Momentum, BioXcel Nears At-Home Approval Milestone

August 18, 2025

DENVER, Colo., Aug 18, 2025 (247marketnews.com)- Today’s news is dominated by regulatory wins, scientific validation, and clinical momentum, as several emerging healthcare and biopharma players are making waves.

Catheter Precision (NYSE:VTAK) officially secured regulatory approval and registration for its LockeT device in the United Kingdom, just months after obtaining CE Mark in May 2025. The LockeT device is a suture retention tool designed for use in cardiac electrophysiology procedures, improving patient recovery and supporting faster hospital discharge.

To accelerate commercialization, the company is expanding its partnership with UK-based HC21, a distributor with €180M in annual revenues and a strong NHS footprint. Fatih Ayoglu, Sales Manager for EMEA & APAC, emphasized that LockeT’s ease of use enables earlier discharge, directly contributing to efforts by the NHS to reduce long-standing waitlists.

Notably, the regulatory milestone comes after Catheter Precision hit a 52-week stock low, signaling potential for a technical rebound as investor sentiment improves.

LIXTE Biotechnology (NASDAQ:LIXT) issued a comprehensive corporate update this week, highlighting $6.5 million in new financing, regained Nasdaq compliance, and key leadership changes. Geordan Pursglove was named CEO and Chairman, while Bas van der Baan transitioned to President and CSO. Two new board members, Jason Sawyer and Michael Holloway, MD, joined the company.

A recent study published in Nature backs LIXTE’s lead compound, LB-100, a PP2A inhibitor being evaluated in combination with immunotherapy. The research, led by Dr. Amir Jazaeri at MD Anderson, showed that patients with PPP2R1A mutations, targeted by LB-100, experienced significantly better survival outcomes with immune checkpoint blockade therapy.

Additionally, LIXTE launched a new preclinical cancer prevention study with the Netherlands Cancer Institute, aimed at targeting early-stage “initiated” cells.

With ongoing clinical trials for ovarian GSK (NYSE:GSK) supported and colorectal cancer Roche (OTCQX:RHHBY) supported, the company appears well-positioned for both scientific and market advancement.

BioXcel Therapeutics (NASDAQ:BTAI) is moving closer to a label expansion for BXCL501 (IGALMI) with positive pre-sNDA feedback from the FDA. The agency signaled alignment on the necessary clinical and manufacturing components, allowing BioXcel to cancel a planned pre-sNDA meeting and proceed with submission, targeted for Q1 2026.

Currently approved for in-hospital treatment of agitation in bipolar and schizophrenia patients, IGALMI’s expansion into the at-home setting would be a first-in-class milestone for psychiatric care. The pivotal SERENITY At-Home Phase 3 trial, completed in August, enrolled 200 patients self-administering the drug during episodes of acute agitation.

Vimal Mehta, Ph.D., CEO, noted the significance of the FDA’s guidance, stating it “reflects a shared commitment to addressing the urgent needs of patients living with bipolar disorder or schizophrenia.” The FDA has already granted the candidate Fast Track designation, further boosting its regulatory momentum.

Other Movers and Developments in Biotech and Pharma

  • Propanc Biopharma (NASDAQ:PPCB) recently uplisted to Nasdaq through a public offering priced at $4.00 per share, expanding investor access and visibility.
  • Soligenix (NASDAQ:SNGX) received orphan drug designation from the FDA for dusquetide, its lead candidate for treating Behçet’s Disease, following promising Phase 2a data.
  • Aspire Biopharma (NASDAQ:ASBP) dosed its first U.S. patient in a Phase I trial of its fast-acting sublingual aspirin in May. Results expected in Q3 could support an accelerated FDA path for this cardiovascular intervention technology.
  • GoodRx (NASDAQ:GDRX), IO Biotech (NASDAQ:IOBT), and ImmunoPrecise Antibodies (NASDAQ:IPA) also remain on watchlists, each navigating unique niches in healthtech, oncology, and antibody discovery, respectively.

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