Precision Optics Customer Receives FDA 510(k) Clearance; Accelerates Production Order for POC Single-Use Endoscope Imaging Assembly
Precision Optics (NASDAQ: POCI) announced that its customer, a surgical robotics company, received FDA 510(k) clearance for its AI-powered platform treating Benign Prostate Hyperplasia. POC designs and manufactures the single-use endoscope imaging assembly for this system. The company has begun production deliveries against a $9 million order, with estimated deliveries of $3.6 million during fiscal year ending June 2025. POC expects significant long-term growth as their customer deploys the new robotic system in the market where they already hold a dominant position.
Precision Optics (NASDAQ: POCI) ha annunciato che il suo cliente, un'azienda di robotica chirurgica, ha ricevuto l'autorizzazione 510(k) della FDA per la sua piattaforma alimentata dall'IA per il trattamento dell'iperplasia prostatica benigna. POC progetta e produce l'assemblaggio di imaging per endoscopi monouso per questo sistema. L'azienda ha iniziato le consegne di produzione relative a un ordine di 9 milioni di dollari, con consegne stimate di 3,6 milioni di dollari durante l'anno fiscale che termina a giugno 2025. POC prevede una significativa crescita a lungo termine man mano che il loro cliente implementa il nuovo sistema robotico nel mercato dove già detiene una posizione dominante.
Precision Optics (NASDAQ: POCI) anunció que su cliente, una empresa de robótica quirúrgica, recibió la autorización 510(k) de la FDA para su plataforma impulsada por IA para el tratamiento de la hiperplasia prostática benigna. POC diseña y fabrica el ensamblaje de imagen de endoscopios desechables para este sistema. La empresa ha comenzado las entregas de producción contra un pedido de 9 millones de dólares, con entregas estimadas de 3,6 millones de dólares durante el año fiscal que termina en junio de 2025. POC espera un crecimiento significativo a largo plazo a medida que su cliente implemente el nuevo sistema robótico en el mercado donde ya tiene una posición dominante.
Precision Optics (NASDAQ: POCI)는 고객인 수술 로봇 회사가 양성 전립선 비대증 치료를 위한 AI 기반 플랫폼에 대해 FDA 510(k) 승인을 받았다고 발표했습니다. POC는 이 시스템을 위한 일회용 내시경 이미징 어셈블리를 설계하고 제조합니다. 회사는 900만 달러 규모의 주문에 대한 생산 배송을 시작했으며, 2025년 6월 회계연도 동안 360만 달러의 배송이 예상됩니다. POC는 고객이 이미 시장에서 지배적인 위치를 점하고 있는 새로운 로봇 시스템을 배포함에 따라 장기적으로 상당한 성장을 기대하고 있습니다.
Precision Optics (NASDAQ: POCI) a annoncé que son client, une entreprise de robotique chirurgicale, a reçu l'autorisation 510(k) de la FDA pour sa plateforme alimentée par IA traitant l'hyperplasie bénigne de la prostate. POC conçoit et fabrique l'ensemble d'imagerie d'endoscopes jetables pour ce système. L'entreprise a commencé les livraisons de production pour un ordre de 9 millions de dollars, avec des livraisons estimées à 3,6 millions de dollars pendant l'exercice se terminant en juin 2025. POC s'attend à une croissance significative à long terme, alors que son client déploie le nouveau système robotique sur le marché où il détient déjà une position dominante.
Precision Optics (NASDAQ: POCI) gab bekannt, dass sein Kunde, ein Unternehmen für chirurgische Robotik, die FDA 510(k)-Zulassung für seine KI-gesteuerte Plattform zur Behandlung der benignen Prostatahyperplasie erhalten hat. POC entwirft und fertigt die Einweg-Endoskop-Bildgebungseinheit für dieses System. Das Unternehmen hat mit den Produktionslieferungen für einen Bestellung über 9 Millionen Dollar begonnen, mit geschätzten Lieferungen von 3,6 Millionen Dollar im Geschäftsjahr, das im Juni 2025 endet. POC erwartet signifikantes langfristiges Wachstum, da der Kunde das neue robotergestützte System auf dem Markt einführt, in dem er bereits eine dominierende Position hält.
- Secured $9 million production order for single-use endoscope imaging assembly
- Expected revenue of $3.6 million for fiscal year 2025 from this order
- Customer received FDA 510(k) clearance, enabling market commercialization
- Strong market position through customer's dominant presence in urology robotics
- None.
Insights
This FDA clearance represents a significant milestone for both POC and its customer in the urology robotics space. The
The customer's established market presence and AI-powered platform suggest substantial growth potential for POC's component sales. The successful integration of advanced imaging technology within reimbursement constraints demonstrates strong product-market fit. For a small-cap company with a
GARDNER, Mass., Oct. 29, 2024 (GLOBE NEWSWIRE) -- Precision Optics Corporation, Inc. (NASDAQ: POCI) (“POC”), a leading designer and manufacturer of advanced optical instruments for the medical and defense industries, today announced that its customer, a surgical robotics company focused on transformative solutions in urology, recently announced FDA 510(k) clearance of its next-generation AI-powered platform for treatment of Benign Prostate Hyperplasia. Precision Optics designed and currently manufactures the single-use endoscope imaging assembly used within the new system.
“We are excited by the news and congratulate our customer’s entire team on receiving FDA 510(k) clearance for their revolutionary robotic surgery system,” stated Dr. Joe Forkey, CEO of Precision Optics. “We are proud to have partnered with our customer in the development of the single-use imaging assembly for this system, which required the use of our unique micro-optics and digital imaging technologies to meet the challenging technical requirements within the critical reimbursement constraints for single-use medical devices. We are grateful for the strong partnership between our technical and production teams which led to our customer reaching the commercialization stage on an accelerated timetable. We are pleased to have already completed deliveries for clinical use.”
“Like our customer, POC is optimistic the market for treatment of Benign Prostate Hyperplasia, which is already a large market, will continue robust growth. Our customer has been very successful already in addressing this market with their AI-drive robotic platform, and we expect over the long-term our business may grow several fold as their success continues.”
POC recently began production deliveries of the endoscope imaging assembly against a
About Precision Optics Corporation
Founded in 1982, Precision Optics is a vertically integrated optics company primarily focused on leveraging its proprietary micro-optics and 3D imaging technologies to the healthcare and defense/aerospace industries by providing services ranging from new product concept through mass manufacture. Utilizing its leading-edge in-house design, prototype, regulatory and fabrication capabilities as well as its Lighthouse Imaging division's electronic imaging expertise and its Ross Optical division's high volume world-wide sourcing, inspecting and production resources, the Company designs and manufactures next-generation product solutions for the most challenging customer requirements. Within healthcare, Precision Optics enables next generation medical device companies around the world to meet the increasing demands of the surgical community who require more enhanced and smaller imaging systems for minimally invasive surgery, including single-use medical devices, as well as 3D endoscopy systems to support the rapid proliferation of surgical robotic systems. In addition to these next generation applications, Precision Optics has supplied top tier medical device companies with a wide variety of optical products for decades, including complex endocouplers and specialized endoscopes. The Company is also leveraging its technical proficiency in micro-optics to enable leading edge defense/aerospace applications which require the highest quality standards and the optimization of size, weight and power. For more information, please visit www.poci.com.
About Forward-Looking Statements
This press release contains forward-looking statements. Forward-looking statements include, but are not limited to, statements that express the Company's intentions, beliefs, expectations, strategies, predictions or any other statements related to the Company's future activities or future events or conditions. These statements are based on current expectations, estimates and projections about the Company's business based, in part, on assumptions made by the Company's management. These statements are not guarantees of future performance and involve risks, uncertainties and assumptions that are difficult to predict. Therefore, actual outcomes and results may differ materially from what is expressed or forecasted in the forward-looking statements due to numerous risk factors, including those risks discussed in the Company's annual report on Form 10-K and in other documents that we file from time to time with the SEC. Any forward-looking statements speak only as of the date on which they are made, and the Company does not undertake any obligation to update any forward-looking statement, except as required by law.
Company Contact:
PRECISION OPTICS CORPORATION
22 East Broadway
Gardner, Massachusetts 01440-3338
Telephone: 978-630-1800
Investor Contact:
LYTHAM PARTNERS, LLC
Robert Blum
Telephone: 602-889-9700
poci@lythampartners.com
FAQ
What is the value of POCI's recent production order for endoscope imaging assemblies?
How much revenue does POCI expect from the endoscope assembly order in fiscal 2025?
What regulatory approval did POCI's customer receive in October 2024?
What product does POCI manufacture for the newly FDA-cleared robotic surgery system?
