RenovoRx Advances Commercialization of RenovoCath® with Several New Purchase Orders, Including Customer Reorders
RenovoRx (NASDAQ: RNXT) announced new purchase orders for its RenovoCath drug-delivery device from several National Cancer Institute-designated centers, including repeat orders from initial customers from December. The company expects to generate initial revenues this quarter, with potential revenue growth through 2025.
The FDA-cleared RenovoCath device is priced between $7,000 to $9,000 per unit, with an expected 5 to 8 annual procedures per patient. Based on these metrics and their initial target customer base, RenovoRx estimates a potential $400 million peak annual U.S. market for RenovoCath as a standalone device.
RenovoRx (NASDAQ: RNXT) ha annunciato nuovi ordini di acquisto per il suo dispositivo di somministrazione di farmaci RenovoCath da diversi centri designati dal National Cancer Institute, inclusi ordini ripetuti da clienti iniziali a partire da dicembre. L'azienda prevede di generare ricavi iniziali in questo trimestre, con una potenziale crescita dei ricavi fino al 2025.
Il dispositivo RenovoCath, approvato dalla FDA, ha un prezzo compreso tra $7,000 e $9,000 per unità, con una previsione di 5 a 8 procedure annuali per paziente. Sulla base di queste metriche e del loro target iniziale di clienti, RenovoRx stima un potenziale mercato annuale di picco di $400 milioni negli Stati Uniti per RenovoCath come dispositivo autonomo.
RenovoRx (NASDAQ: RNXT) anunció nuevos pedidos de compra para su dispositivo de entrega de medicamentos RenovoCath de varios centros designados por el Instituto Nacional del Cáncer, incluidos pedidos repetidos de clientes iniciales desde diciembre. La empresa espera generar ingresos iniciales este trimestre, con un crecimiento potencial de ingresos hasta 2025.
El dispositivo RenovoCath, aprobado por la FDA, tiene un precio entre $7,000 y $9,000 por unidad, con un promedio de 5 a 8 procedimientos anuales por paciente. Basándose en estas métricas y su base de clientes objetivo inicial, RenovoRx estima un potencial mercado anual pico de $400 millones en EE. UU. para RenovoCath como dispositivo independiente.
RenovoRx (NASDAQ: RNXT)는 여러 국립암연구소(National Cancer Institute) 지정 센터에서 RenovoCath 약물 전달 장치에 대한 새로운 구매 주문을 발표했으며, 12월부터 초기 고객으로부터 반복 주문을 받았습니다. 이 회사는 이번 분기에 초기 수익을 창출할 것으로 예상하며, 2025년까지 수익 성장이 가능할 것으로 보고 있습니다.
FDA 승인을 받은 RenovoCath 장치는 단위당 $7,000에서 $9,000 사이의 가격이 책정되어 있으며, 환자당 연간 5에서 8회의 절차가 예상됩니다. 이러한 지표와 초기 목표 고객 기반을 바탕으로 RenovoRx는 RenovoCath가 독립 장치로서 미국에서 연간 최대 $400 million의 시장을 가질 것으로 추정하고 있습니다.
RenovoRx (NASDAQ: RNXT) a annoncé de nouvelles commandes d'achat pour son dispositif de délivrance de médicaments RenovoCath de plusieurs centres désignés par l'Institut national du cancer, y compris des commandes répétées de clients initiaux depuis décembre. L'entreprise s'attend à générer des revenus initiaux ce trimestre, avec une croissance potentielle des revenus jusqu'en 2025.
Le dispositif RenovoCath, approuvé par la FDA, est proposé à un prix compris entre $7,000 et $9,000 par unité, avec une prévision de 5 à 8 procédures annuelles par patient. Sur la base de ces indicateurs et de leur base de clients cible initiale, RenovoRx estime un potentiel de marché annuel de pointe de $400 millions aux États-Unis pour RenovoCath en tant que dispositif autonome.
RenovoRx (NASDAQ: RNXT) hat neue Bestellungen für sein RenovoCath Arzneimittelabgabegerät von mehreren vom National Cancer Institute (NCI) ausgewiesenen Zentren angekündigt, einschließlich Wiederbestellungen von ersten Kunden seit Dezember. Das Unternehmen erwartet, in diesem Quartal erste Einnahmen zu generieren, mit einem potenziellen Umsatzwachstum bis 2025.
Das von der FDA zugelassene RenovoCath-Gerät kostet zwischen $7,000 und $9,000 pro Einheit, mit einer erwarteten jährlichen Anzahl von 5 bis 8 Eingriffen pro Patient. Basierend auf diesen Kennzahlen und ihrer anfänglichen Zielkundengruppe schätzt RenovoRx einen potenziellen Jahresmarkt von $400 Millionen in den USA für RenovoCath als eigenständiges Gerät.
- Secured new purchase orders from National Cancer Institute centers
- Received repeat orders from initial customers
- Revenue generation expected to begin this quarter
- Large market opportunity: $400M potential peak annual US sales
- Premium pricing: $7,000-$9,000 per unit
- No current revenue generation
- Dependence on high-cost specialty medical device
Insights
RenovoRx's announcement marks a critical inflection point as the company transitions from development to commercialization phase with its FDA-cleared RenovoCath device. The securing of purchase orders from prestigious National Cancer Institute-designated centers, along with repeat orders from initial customers, provides important validation for the technology's clinical utility.
The company's $400 million peak annual U.S. market estimate appears substantial relative to RNXT's current $35 million market capitalization, representing a significant growth opportunity if executed successfully. With pricing of $7,000-$9,000 per unit and 5-8 procedures per patient annually, the business model suggests attractive recurring revenue potential. At the midpoint of pricing ($8,000) and procedures (6.5), each patient could generate approximately $52,000 in annual revenue.
However, investors should note several critical factors: First, the announcement lacks specific order quantities or revenue projections, making near-term financial impact difficult to quantify. Second, as a micro-cap company likely facing cash constraints, execution of the commercial ramp will be important to watch in coming quarters. Third, while the company mentions "strengthened negotiation position" with potential commercial collaborators, no definitive partnership agreements are announced.
The repeat orders are particularly meaningful as they indicate product satisfaction and potential for growing utilization rates. The specialized nature of the device for targeted therapeutic delivery in oncology suggests a defensible market position, though adoption rates in specialized medical devices typically follow an S-curve with gradual initial uptake.
This milestone represents a significant step forward, but investors should monitor upcoming quarterly reports for concrete revenue figures, customer acquisition rates, and utilization metrics to validate the commercial opportunity.
Initial Revenues Expected this Quarter, and Customer Pipeline for RenovoCath Standalone Device Continues to Expand, Including High Volume National Cancer Institute-Designated Centers
RenovoCath Gaining Validation in an Initial U.S. Market Estimated at
Additionally, RenovoRx reported that utilization of RenovoCath devices by its initial customers announced this past December has led to repeat purchase orders. Together, these announcements demonstrate that RenovoRx is continuing on the path to initial revenue generation from RenovoCath sales this quarter and that revenues could begin to ramp during the course of 2025.
RenovoRx continues to expand the pipeline of medical institutions that have expressed interest in RenovoCath as a standalone device that addresses high unmet medical needs. RenovoRx expects an average of 5 to 8 annual procedures per patient and pricing similar to other specialty catheters on the market today, ranging from
“The commercialization momentum with both new and now repeat customers for our proprietary RenovoCath device has accelerated through expanded relationships with high-volume oncology centers across the country. This not only puts us in a position to potentially generate and grow our initial revenues on our own but also puts us in a strengthened negotiation position with potential commercial sales collaborators,” said Shaun Bagai, CEO of RenovoRx. “We are encouraged by the reception for RenovoCath for targeted therapeutic delivery and potential benefits for improved patient outcomes. We believe targeted therapeutic delivery with RenovoCath via our TAMP technology has the potential to transform oncology treatment by enabling precise delivery of agents. We look forward to riding this momentum forward and providing updates as the year progresses.”
About RenovoCath
Based on its FDA clearance, RenovoCath® is intended for the isolation of blood flow and delivery of fluids, including diagnostic and/or therapeutic agents, to selected sites in the peripheral vascular system. RenovoCath is also indicated for temporary vessel occlusion in applications including arteriography, preoperative occlusion, and chemotherapeutic drug infusion. For further information regarding our RenovoCath Instructions for Use (“IFU”), please see: IFU-10004-Rev.-F-Universal-IFU.pdf.
About RenovoRx, Inc.
RenovoRx is a life sciences company developing innovative targeted oncology therapies and commercializing RenovoCath®, a novel,
In addition to the RenovoCath device, RenovoRx is also evaluating our novel Phase III drug-device oncology product candidate. It is being investigated under a
The intra-arterial infusion of gemcitabine by the RenovoCath catheter is currently under investigation and has not been approved for commercial sale. RenovoCath with gemcitabine received Orphan Drug Designation for pancreatic cancer and bile duct cancer, which provides 7 years of market exclusivity upon NDA approval by the FDA.
RenovoRx is also engaged in implementing commercialization strategies utilizing its TAMP technology and FDA-cleared RenovoCath device as stand-alone device. In December 2024, RenovoRx announced the receipt of its first commercial purchase orders for RenovoCath devices. Additionally, certain of these customers have already initiated repeat orders as RenovoRx works to expand the number medical institutions that have initiated the process for RenovoCath purchase orders, including several esteemed, high volume National Cancer Institute-designated centers. To meet and satisfy the anticipated demand, RenovoRx will continue to actively explore further revenue-generating activity either on its own or in tandem with a medical device commercial partner.
For more information, visit www.renovorx.com. Follow RenovoRx on Facebook, LinkedIn, and X.
Cautionary Note Regarding Forward-Looking Statements
This press release and statements of the Company’s management made in connection described herein contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, and Section 21E of the Securities Exchange Act of 1934, including but not limited to statements regarding (i) our pre-clinical and clinical trials and studies, including the overall timing and timing for additional interim data readouts for our ongoing TIGeR-PaC Phase III clinical trial study in LAPC, (ii) the potential of RenovoCath® or TAMP™ as standalone commercial products, our anticipated timing for revenue generation from RenovoCath sales, and our commercialization plans in general, including our estimates of total addressable market (iii) the potential for our product candidates to treat or provide clinically meaningful outcomes for certain medical conditions or diseases and (iv) our efforts to explore commercialization strategies utilizing our TAMP technology. Statements that are not purely historical are forward-looking statements. The forward-looking statements contained herein are based upon our current expectations and beliefs regarding future events, many of which, by their nature, are inherently uncertain, outside of our control and involve assumptions that may never materialize or may prove to be incorrect. These may include estimates, projections and statements relating to our research and development plans, commercial plans, intellectual property development, clinical trials, our therapy platform, business plans, financing plans, objectives and expected operating results, which are based on current expectations and assumptions that are subject to significant known and unknown risks and uncertainties that may cause actual results to differ materially and adversely from those expressed or implied by these forward-looking statements. These statements may be identified using words such as “may,” “expects,” “plans,” “aims,” “anticipates,” “believes,” “forecasts,” “estimates,” “intends,” and “potential,” or the negative of these terms or other comparable terminology regarding RenovoRx’s expectations strategy, plans or intentions, although not all forward-looking statements contain these words. These forward-looking statements are subject to a number of risks, uncertainties and assumptions, that could cause actual events to differ materially from those projected or indicated by such statements, including, among other things: (i) the risk that our exploration of commercial opportunities for our TAMP technology may not lead to viable or repeating revenue generating operations; (ii) circumstances which would adversely impact our ability to efficiently utilize our cash resources on hand or raise additional funding, (iii) the timing of the initiation, progress and potential results (including the results of interim analyses) of TIGeR-PaC and any other preclinical studies, clinical trials and our research programs; (iv) the possibility that interim results may not be predictive of the outcome of our clinical trials, which may not demonstrate sufficient safety and efficacy to support regulatory approval of our product candidate, (v) that the applicable regulatory authorities may disagree with our interpretation of the data; research and clinical development plans and timelines, and the regulatory process for our product candidates; (vi) future potential regulatory milestones for our product candidates, including those related to current and planned clinical studies; (vii) our ability to use and expand our therapy platform to build a pipeline of product candidates; (viii) our ability to advance product candidates into, and successfully complete, clinical trials; (ix) the timing or likelihood of regulatory filings and approvals; (x) our estimates of the number of patients who suffer from the diseases we are targeting and the number of patients that may enroll in our clinical trials; (xi) the commercialization potential of our product candidates, if approved; (xii) our ability and the potential to successfully manufacture and supply our product candidates for clinical trials and for commercial use, if approved; (xiii) future strategic arrangements and/or collaborations and the potential benefits of such arrangements; (xiv) our estimates regarding expenses, future revenue, capital requirements and needs for additional financing and our ability to obtain additional capital; (xv) the sufficiency of our existing cash and cash equivalents to fund our future operating expenses and capital expenditure requirements; (xvi) our ability to retain the continued service of our key personnel and to identify, and hire and retain additional qualified personnel; (xvii) the implementation of our strategic plans for our business and product candidates; (xviii) the scope of protection we are able to establish and maintain for intellectual property rights, including our therapy platform, product candidates and research programs; (xix) our ability to contract with third-party suppliers and manufacturers and their ability to perform adequately; (xx) the pricing, coverage and reimbursement of our product candidates, if approved; and (xxi) developments relating to our competitors and our industry, including competing product candidates and therapies. Information regarding the foregoing and additional risks may be found in the section entitled “Risk Factors” in documents that we file from time to time with the Securities and Exchange Commission.
Forward-looking statements included herein are made as of the date hereof, and RenovoRx does not undertake any obligation to update publicly such forward-looking statements to reflect subsequent events or circumstances, except as required by law.
View source version on businesswire.com: https://www.businesswire.com/news/home/20250226636030/en/
KCSA Strategic Communications
Valter Pinto or Jack Perkins
T: 212-896-1254
RenovoRX@KCSA.com
Source: RenovoRx, Inc.
FAQ
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