Pacira BioSciences Receives FDA 510k Clearance for New iovera° SmartTip to Manage Chronic Low Back Pain via Long-lasting Medial Branch Nerve Block
Pacira BioSciences (Nasdaq: PCRX) has received FDA 510(k) clearance for a new Smart Tip designed for the iovera° system to manage chronic low back pain via long-lasting medial branch nerve block. The iovera° system uses cryoneurolysis, applying focused cold therapy to nerves to interrupt pain signals temporarily. The new 25-gauge, 180-mm Smart Tip treats deeper nerves, including the medial branch nerve, and is designed to relieve chronic low back pain associated with facet-mediated pain.
Chronic low back pain is a significant health issue in the U.S., leading to disability and opioid prescriptions. The iovera° system provides an alternative to radiofrequency ablation (RFA), which has limitations like delayed pain relief and potential tissue damage. A single-center randomized pilot study showed that patients treated with iovera° reported pain scores more than 2 points lower at 180 and 360 days compared to RFA-treated patients. Additionally, iovera° patients exhibited significant functional improvements and greater satisfaction with pain management.
The FDA clearance of this new Smart Tip is a step forward in offering drug-free, effective pain relief for millions of Americans with chronic back pain.
Pacira BioSciences (Nasdaq: PCRX) ha ricevuto l'
Il dolore lombare cronico è un problema di salute significativo negli Stati Uniti, che porta a disabilità e prescrizioni di oppioidi. Il sistema iovera° fornisce un'alternativa all'ablazione a radiofrequenza (RFA), che ha limitazioni come il ritardo nel sollievo dal dolore e potenziali danni ai tessuti. Uno studio pilota randomizzato condotto in un singolo centro ha mostrato che i pazienti trattati con iovera° hanno riportato punteggi del dolore inferiori di oltre 2 punti a 180 e 360 giorni rispetto ai pazienti trattati con RFA. Inoltre, i pazienti iovera° hanno mostrato significativi miglioramenti funzionali e maggiore soddisfazione nella gestione del dolore.
L'approvazione della FDA di questo nuovo Smart Tip rappresenta un passo avanti nell'offrire un sollievo dal dolore efficace e privo di farmaci per milioni di americani con dolore cronico alla schiena.
Pacira BioSciences (Nasdaq: PCRX) ha recibido la autorización 510(k) de la FDA para una nueva Smart Tip diseñada para el sistema iovera° para gestionar el dolor lumbar crónico a través de un bloqueo prolongado del nervio del ramo medial. El sistema iovera° utiliza crioneurolysis, aplicando terapia de frío focalizada a los nervios para interrumpir temporalmente las señales de dolor. La nueva Smart Tip de 25 gauge y 180 mm trata nervios más profundos, incluido el nervio del ramo medial, y está diseñada para aliviar el dolor lumbar crónico asociado con el dolor mediado por facetas.
El dolor lumbar crónico es un problema de salud importante en EE. UU., que lleva a discapacidades y prescripciones de opioides. El sistema iovera° proporciona una alternativa a la ablación por radiofrecuencia (RFA), que tiene limitaciones como el retraso en el alivio del dolor y el posible daño a los tejidos. Un estudio piloto aleatorio de un solo centro mostró que los pacientes tratados con iovera° informaron puntuaciones de dolor más de 2 puntos más bajas a los 180 y 360 días en comparación con los pacientes tratados con RFA. Además, los pacientes de iovera° mostraron mejoras funcionales significativas y una mayor satisfacción con la gestión del dolor.
La autorización de la FDA para esta nueva Smart Tip es un avance en la oferta de alivio del dolor efectivo y sin medicamentos para millones de estadounidenses que padecen dolor crónico de espalda.
Pacira BioSciences (Nasdaq: PCRX)가 FDA 510(k) 승인을 받아 만성 요통을 관리하기 위해 iovera° 시스템에 설계된 새로운 Smart Tip을 최초로 공개했습니다. iovera° 시스템은 냉각 신경절제술을 사용하여 신경에 집중된 냉각 요법을 적용하여 통증 신호를 일시적으로 차단합니다. 새로운 25게이지, 180mm Smart Tip은 깊은 신경(내측 가지 신경 포함)을 치료하며, 관절면으로 유발된 통증과 관련된 만성 요통을 완화하도록 설계되었습니다.
만성 요통은 미국에서 중요한 건강 문제로, 장애와 오피오이드 처방으로 이어집니다. iovera° 시스템은 지연된 통증 완화와 잠재적인 조직 손상과 같은 제한점이 있는 고주파 절제술(RFA)에 대한 대안을 제공합니다. 단일 센터 무작위 파일럿 연구에 따르면 iovera°로 치료받은 환자는 RFA 치료를 받은 환자보다 180일 및 360일 후 통증 점수가 2점 이상 낮았다고 보고되었습니다. 또한, iovera° 환자는 기능 개선과 통증 관리에 대한 만족도가显著하게 향상된 것으로 나타났습니다.
이 새로운 Smart Tip의 FDA 승인은 만성 요통에 시달리는 수백만 미국인에게 약물 없는 효과적인 통증 완화를 제공하는 중요한 진전을 의미합니다.
Pacira BioSciences (Nasdaq: PCRX) a reçu l'autorisation 510(k) de la FDA pour un nouveau Smart Tip conçu pour le système iovera° afin de gérer la douleur lombaire chronique par un blocage durable du nerf du bras médial. Le système iovera° utilise la cryoneurolyse, appliquant une thérapie par le froid ciblée sur les nerfs pour interrompre temporairement les signaux de douleur. Le nouveau Smart Tip de 25 gauge et 180 mm traite des nerfs plus profonds, y compris le nerf du bras médial, et est conçu pour soulager la douleur lombaire chronique associée à la douleur médiée par les facettes.
La douleur lombaire chronique est un problème de santé significatif aux États-Unis, entraînant des incapacités et des prescriptions d'opioïdes. Le système iovera° offre une alternative à l'ablation par radiofréquence (RFA), qui présente des limites telles que le retard dans le soulagement de la douleur et les dommages potentiels tissulaires. Une étude pilote randomisée réalisée dans un seul centre a montré que les patients traités avec iovera° ont signalé des scores de douleur supérieurs de plus de 2 points après 180 et 360 jours par rapport aux patients traités par RFA. De plus, les patients iovera° ont montré des améliorations fonctionnelles significatives et une plus grande satisfaction concernant la gestion de la douleur.
L'autorisation de la FDA pour ce nouveau Smart Tip représente un pas en avant dans l'offre d'un soulagement efficace de la douleur sans médicament pour des millions d'Américains souffrant de douleurs chroniques au dos.
Pacira BioSciences (Nasdaq: PCRX) hat die FDA 510(k) Genehmigung für eine neue Smart Tip erhalten, die für das iovera°-System zur Behandlung von chronischen Rückenschmerzen durch langanhaltende Blockade des medialen Nervenarms entwickelt wurde. Das iovera°-System verwendet Kryoneurolyse, bei der fokussierte Kältetherapie auf Nerven angewendet wird, um Schmerzsignale vorübergehend zu unterbrechen. Die neue 25-Gauge, 180-mm Smart Tip behandelt tiefere Nerven, einschließlich des medialen Nervenarms, und wurde entwickelt, um chronische Rückenschmerzen, die mit facettengestütztem Schmerz verbunden sind, zu lindern.
Chronische Rückenschmerzen sind ein erhebliches Gesundheitsproblem in den USA, das zu Behinderungen und opioidbasierten Verschreibungen führt. Das iovera°-System bietet eine Alternative zur Radiofrequenzablation (RFA), die Einschränkungen wie verzögerten Schmerzlindereffekten und potenziellen Gewebeschäden hat. Eine randomisierte Pilotstudie in einem einzelnen Zentrum zeigte, dass Patienten, die mit iovera° behandelt wurden, 180 und 360 Tage nach der Behandlung mehr als 2 Punkte niedrigere Schmerzwerte berichteten als Patienten, die mit RFA behandelt wurden. Darüber hinaus zeigten iovera°-Patienten signifikante funktionelle Verbesserungen und höhere Zufriedenheit mit dem Schmerzmanagement.
Die Genehmigung der FDA für diese neue Smart Tip stellt einen Fortschritt bei der Bereitstellung von medikamentenfreier, effektiver Schmerzlinderung für Millionen von Amerikanern mit chronischen Rückenschmerzen dar.
- FDA clearance for new Smart Tip for iovera° system.
- Provides an alternative to opioid prescriptions.
- Patients reported pain scores more than 2 points lower at 180 and 360 days compared to RFA.
- Statistically and clinically significant improvements in functional outcomes.
- No serious adverse events observed in the study.
- RFA treatment has limitations like delayed pain relief and potential tissue damage.
Insights
The FDA 510(k) clearance for Pacira's new iovera° SmartTip represents a significant advancement in chronic low back pain management. The 25-gauge 180-mm design specifically targeting medial branch nerves through cryoneurolysis is technically superior to existing options. The device's ability to form ice balls at deeper peripheral nerves while using a cannula introduces a novel approach to nerve blocking.
Comparative data showing 2-point lower pain scores at 180 and 360 days versus RFA is clinically meaningful, especially considering the improvement from moderate to minimal disability in ODI scores. The immediate onset of action addresses a critical gap in current treatment options, as RFA typically requires 1-2 weeks for effect. The absence of heat-related tissue damage and neuritis risk significantly improves the safety profile.
From a market perspective, with 28-30 million Americans seeking chronic back pain treatment but only 2-3 million receiving interventional procedures, this represents a substantial market opportunity for Pacira.
This FDA clearance positions Pacira to capture a larger share of the interventional pain management market. The 25 million patient gap between those seeking treatment and receiving interventional procedures represents a massive untapped market opportunity. The superior clinical outcomes compared to RFA provide a compelling value proposition for both healthcare providers and payers.
Back pain's status as the leading cause of disability and work absences creates significant economic incentives for adoption. The reduced risk of opioid dependency through non-pharmacological intervention aligns with current healthcare priorities and regulatory trends. Market penetration potential is substantial, particularly given the device's demonstrated superiority in patient satisfaction and functional outcomes compared to RFA.
PARSIPPANY, N.J., Jan. 07, 2025 (GLOBE NEWSWIRE) -- Pacira BioSciences, Inc. (Nasdaq: PCRX), the industry leader in the delivery of innovative, non-opioid pain therapies to transform the lives of patients, announced today that it has received clearance from the U.S. Food & Drug Administration (FDA) to market a new Smart Tip designed to access the medial branch nerves to manage chronic low back pain.
The ioveraº system is an innovative, FDA-cleared, drug-free treatment that relieves pain via cryoneurolysis—a process whereby focused cold therapy is applied to a targeted nerve, temporarily interrupting its ability to transmit pain signals. Pain relief is typically experienced immediately after treatment, with the effects lasting for months as the nerve gradually regenerates.
To date, the ioveraº portfolio has consisted of either a three-pronged Smart Tip featuring 8.5-mm long 27-gauge needles to treat superficial nerves or a single, 90-mm long, 20-guage Smart Tip ideally suited to treat deeper nerves. It is most commonly used to treat knee pain, but frequently used to manage pain in the hip, shoulder, chest, foot and ankle, and more.
Now, this new, 25-gauge 180-mm Smart Tip will allow for the treatment of deeper nerves, such as the medial branch nerve and is specifically designed so that it can relieve chronic low back pain associated with facet mediated pain. This longer-needle Smart Tip is uniquely designed for use through a cannula or introducer, providing the ability for ice ball formation at deeper peripheral nerves.
Chronic low back pain remains a pervasive health challenge in the United States:
- Back pain is the leading cause of disability nationwide.
- It is also the most common reason for extended work absences.
- Chronic back pain is the number one indication for opioid prescriptions, often leading to dependency and abuse.
- Annually, 28 to 30 million Americans seek treatment for chronic back pain, yet only 2 to 3 million undergo interventional procedures.
With the introduction of this new iovera° Smart Tip, Pacira aims to address these gaps and elevate the standard of care. This FDA-cleared innovation offers a compelling alternative to conventional treatments such as radiofrequency ablation (RFA) ablation, which has substantial limitations. With RFA, patients may not get the effects of pain relief until 1-2 weeks after treatment, further the intense heat can damage surrounding tissue and blood vessels, and tissue damage may lead to painful neuritis (inflammation in the nerves).
A single-center randomized pilot study conducted by Interventional Pain Management and Physical Medicine and Rehabilitation (PM&R) Specialist Martin Ferrillo, DO, of Albany and Saratoga Centers for Pain Management, compared iovera° cryoneurolysis to RFA for facet-mediated chronic back pain.
The findings underscore the significant advantages of the iovera° system:
- Patients treated with iovera° reported pain scores that were more than 2 points lower at 180 and 360 days compared to those treated with RFA on the 0-10 NRS Pain scale.
- At 360 days, patients in the iovera° group showed statistically and clinically significant improvements in functional outcomes, as evidenced by average Oswestry Disability Index (ODI) scores improving from moderate disability to minimal disability.
- More iovera° patients expressed satisfaction with their pain management compared to those receiving RFA.
- No serious adverse events were observed over the course of the study.
“The FDA clearance of this new iovera° Smart Tip is a pivotal step forward, offering patients an innovative, drug-free solution that delivers meaningful and lasting pain relief” said Jonathan Slonin, MD, Chief Medical Officer of Pacira BioSciences. “This achievement reflects our dedication to improving quality of life for the millions of Americans living with chronic back pain.”
About Pacira
Pacira delivers innovative, non-opioid pain therapies to transform the lives of patients. Pacira has three commercial-stage non-opioid treatments: EXPAREL® (bupivacaine liposome injectable suspension), a long-acting local analgesic currently approved for infiltration, fascial plane block, and as an interscalene brachial plexus nerve block for postsurgical pain management; ZILRETTA® (triamcinolone acetonide extended-release injectable suspension), an extended-release, intra-articular injection indicated for the management of osteoarthritis knee pain; and ioveraº®, a novel, handheld device for delivering immediate, long-acting, drug-free pain control using precise, controlled doses of cold temperature to a targeted nerve. The company is also advancing the development of PCRX-201, a novel locally administered gene therapy with the potential to treat large prevalent diseases like osteoarthritis. To learn more about Pacira, visit www.pacira.com.
About iovera°®
The iovera° system is used to destroy tissue during surgical procedures by applying freezing cold. It can also be used to produce lesions in peripheral nervous tissue by the application of cold to the selected site for the blocking of pain. It is also indicated for the relief of pain and symptoms associated with osteoarthritis of the knee for up to 90 days. In one study, the majority of the patients suffering from osteoarthritis of the knee experienced pain and system relief beyond 150 days. When stimulation compatible components are used, the iovera° system can also facilitate targeting nerve location by conducting electrical nerve stimulation from a compatible 3rd party nerve stimulator. The iovera° system is not indicated for treatment of central nervous system tissue.
Important Safety Information
- Do not receive treatment with iovera° if you experience hypersensitivity to cold or have open and/or infected wounds near the treatment site.
- You may experience bruising, swelling, inflammation and/or redness, local pain and/or tenderness, and altered feeling at the site of application.
- In treatment area(s), you may experience damage to the skin, skin darkening or lightening, and dimples in the skin.
- You may experience a temporary loss of your ability to use your muscles normally outside of the treatment area.
- Talk to your doctor before receiving treatment with iovera°.
Forward-Looking Statements
Any statements in this press release about Pacira’s future expectations, plans, trends, outlook, projections and prospects, and other statements containing the words “anticipate,” “believe,” “can,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “project,” “should,” “will,” “would,” and similar expressions, constitute forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), and the Private Securities Litigation Reform Act of 1995, including, without limitation, statements related to our future outlook, our intellectual property and patent terms, our growth and future operating results and trends, our strategy, plans, objectives, expectations (financial or otherwise) and intentions, future financial results and growth potential, including our plans with respect to the repayment of our indebtedness, anticipated product portfolio, development programs, development of products, strategic alliances, plans with respect to the Non-Opioids Prevent Addiction in the Nation (“NOPAIN”) Act and other statements that are not historical facts. For this purpose, any statement that is not a statement of historical fact should be considered a forward-looking statement. We cannot assure you that our estimates, assumptions and expectations will prove to have been correct. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including risks relating to, among others: the integration of our new chief executive officer; risks associated with acquisitions, such as the risk that the acquired businesses will not be integrated successfully, that such integration may be more difficult, time-consuming or costly than expected or that the expected benefits of the transaction will not occur; our manufacturing and supply chain, global and U.S. economic conditions (including inflation and rising interest rates), and our business, including our revenues, financial condition, cash flow and results of operations; the success of our sales and manufacturing efforts in support of the commercialization of EXPAREL, ZILRETTA and iovera°; the rate and degree of market acceptance of EXPAREL, ZILRETTA and iovera°; the size and growth of the potential markets for EXPAREL, ZILRETTA and iovera° and our ability to serve those markets; our plans to expand the use of EXPAREL, ZILRETTA and iovera° to additional indications and opportunities, and the timing and success of any related clinical trials for EXPAREL, ZILRETTA and iovera°; the commercial success of EXPAREL, ZILRETTA and iovera°; the related timing and success of U.S. Food and Drug Administration supplemental New Drug Applications and premarket notification 510(k)s; the related timing and success of European Medicines Agency Marketing Authorization Applications; our plans to evaluate, develop and pursue additional product candidates utilizing our proprietary multivesicular liposome (“pMVL”) drug delivery technology; the approval of the commercialization of our products in other jurisdictions; clinical trials in support of an existing or potential pMVL-based product; our commercialization and marketing capabilities; our ability to successfully complete capital projects; the outcome of any litigation; the ability to successfully integrate any future acquisitions into our existing business; the recoverability of our deferred tax assets; assumptions associated with contingent consideration payments; assumptions used for estimated future cash flows associated with determining the fair value of the Company; the anticipated funding or benefits of our share repurchase program; and factors discussed in the “Risk Factors” of our most recent Annual Report on Form 10-K and in other filings that we periodically make with the Securities and Exchange Commission (the “SEC”). In addition, the forward-looking statements included in this press release represent our views as of the date of this press release. Important factors could cause actual results to differ materially from those indicated or implied by forward-looking statements, and as such we anticipate that subsequent events and developments will cause our views to change. Except as required by applicable law, we undertake no intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, and readers should not rely on these forward-looking statements as representing our views as of any date subsequent to the date of this press release.
FAQ
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