Although there are many well established healthcare stocks among ASX listed companies, some are showing further growth capacity. Two of such potential growth companies are
Orthocell Limited (ASX: OCC)
Orthocell Limited (ASX: OCC) has made significant strides in the commercialization of its nerve repair product, Remplir™, with several major announcements in December 2024. The company submitted its U.S. FDA 510(k) regulatory application for Remplir™ on 19 December, targeting the US$1.6 billion U.S. nerve repair market. The submission follows a successful pivotal study, which met all regulatory endpoints and provided the necessary data for FDA clearance. With the FDA’s 90-day review process, Orthocell anticipates clearance by late March or early April 2025, and the company is already preparing for the U.S. market launch, including the hiring of key sales and medical affairs executives.
In addition to its U.S. regulatory progress, Orthocell achieved a significant milestone in the Southeast Asian market. On 12 December, the company announced its first sales of Remplir™ in Singapore, ahead of the planned market launch in early 2025. This follows the product’s regulatory approval in Singapore in October 2024, with Orthocell’s distribution partner, Device Technologies Asia (DVT Asia), moving swiftly to begin sales. The Singapore market is viewed as a strategic gateway for expansion into other ASEAN countries, further validating Orthocell’s commitment to global market penetration.
Earlier in December, Orthocell also confirmed that its pivotal U.S. FDA regulatory study met all required endpoints, demonstrating the safety and efficacy of Remplir™ for peripheral nerve repair. With encouraging clinical data showing an 85% functional recovery rate in nerve reconstructions, the company is set to make further regulatory submissions in key markets like Canada, the U.K., and Europe. Orthocell’s strong financial position, with around $33 million in cash, positions it well to drive its market entry into the U.S. and expand its global presence in nerve repair surgery.
Botanix Pharmaceuticals Limited (ASX: BOT)
Botanix Pharmaceuticals Limited (ASX: BOT) has achieved a significant milestone in its transition to a commercial-stage pharmaceutical company, announcing on December 17, 2024, that initial prescriptions for Sofdra™ (sofpironium) topical gel, 12.45% have been shipped to patients. This development follows the US FDA approval of Sofdra, positioning it as the only new chemical entity specifically designed for the treatment of axillary hyperhidrosis, or excessive underarm sweating. The product addresses an underserved market of approximately 10 million individuals and is set for full commercial launch in Q1 2025.
The company has made substantial progress in preparing for commercialization, including the implementation of the Sofdra Patient Experience Program to refine its telehealth and fulfillment platform. Over the past year, Botanix has grown its team from fewer than 10 to over 25 employees, adding experienced professionals in sales, marketing, and operations. This expansion will double with the hiring of 27 sales representatives who will focus on engaging dermatologists after the upcoming sales launch meeting. Complementing this effort, Botanix plans to initiate a direct-to-consumer advertising campaign to drive awareness and connect unserved patients with its telehealth solutions.
Engagement with dermatologists and patients has been robust, with insights gathered from interviews and meetings with high prescribers and key opinion leaders at prominent dermatology conferences. The company’s strong relationships with leading dermatologists, combined with strategic marketing efforts, have generated anticipation for Sofdra’s launch. Concurrently, Botanix has made meaningful strides with payers, executing initial contracts and advancing negotiations for commercial and Medicaid coverage. These agreements align with the company’s pricing, rebate, and access expectations, reflecting over a year of preparation. Botanix is now poised to enter a high-growth market with a differentiated product, supported by a focused sales strategy and a growing commercial infrastructure. The launch of Sofdra marks a pivotal step in the company’s ambition to establish itself as a leading independent dermatology company. Early sales performance and execution will be critical factors for investors as Botanix begins this next phase of growth.
Source: Company’s Report
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