WARNING LETTER
Next Science LLC
MARCS-CMS 698114 —
February 21, 2025
Delivery Method:
VIA Electronic Mail
Product:
Medical Devices
Recipient:
Recipient Name
Jon E. Swanson
Recipient Title
COO
Next Science LLC
10550 Deerwood Park Blvd. Ste 300
Jacksonville
,
FL
32256
United States
(b)(6)@nextscience.com
(b)(6)@nextscience.com
Issuing Office:
Center for Devices and Radiological Health
United States
WARNING LETTER
CMS # 698114
February 21, 2025
Dear Mr. Swanson:
During an inspection of your firm located in Jacksonville, Florida on August 12 through September 5, 2024, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures wound gels under the brand names SURGX® and BLASTX®, and wound irrigation solutions under the brand names XPERIENCE® and Bactisure®. These products include devices under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h), because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body.
Lack of Marketing Authorization
Our inspection and review of your firm’s website (https://www.nextscience.com/) determined that the XPERIENCE®, BLASTX® and SURGX® products are adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because your firm does not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), or an approved application for an investigational device exemption under section 520(g) of the Act, 21 U.S.C. § 360j(g) for the products, as described and marketed. These products are also misbranded under section 502(o) of the Act, 21 U.S.C. § 352(o), because your firm did not notify the agency of its intent to introduce the products into interstate commerce for commercial distribution, as required by section 510(k) of the Act, 21 U.S.C. § 360(k). For a product requiring premarket approval, the notification required by section 510(k) is deemed satisfied when a PMA is pending before the agency. 21 CFR 807.81(b).
The kind of information that your firm needs to submit in order to obtain approval or clearance for a device is described on the Internet at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/default.htm. The FDA will evaluate the information that your firm submits and decide whether the product may be legally marketed. Our office requests that your firm cease any activities that result in the misbranding or adulteration of the products.
XPERIENCE®
Your XPERIENCE® product was cleared under K203835 as MIS Solution with the following indications for use: “MIS Solution is indicated for use in cleansing and removal of debris, including microorganisms, from wounds.” However, based on our inspection and review of your firm’s website, FDA is aware that you are marketing these products without clearance or approval for the following uses in your marketing materials and website (https://www.nextscience.com/xperience/), including but not limited to:
“XPERIENCE rinses away debris and microorganisms from the surgical wound site.”
“XPERIENCE does not have cytotoxic effects on osteoblasts. Cell viability and bone growth and healing were shown to be more favorable compared to 10% Betadine.”
“XPERIENCE is cleared for use in a variety of orthopedic surgeries, including arthroplasty, orthopedic trauma, spine, podiatric, and plastics.”
“XPERIENCE is compatible with most commonly used implants, including hydroxyapatite (HA) coated implants, and closure methods.”
“XPERIENCE compatibility with surgical implants and closure methods (316 Stainless Steel, Chrome Alloy, Nylon Sutures, Polyethylene Sutures, Polyethylene, Polydimethylsulfoxide, Polyethylene Sutures, Polysulphone, Silk Sutures, Titanium, Tivanium and Hydroxyapatit Implants).”
“5+ hours of ongoing, broad-spectrum efficacy.”
These claims were not reviewed as part of your premarket notification materials submitted to FDA and do not appear to be within the scope of the clearance issued under K203835. These claims also appear to constitute major changes or modifications in the intended use and could significantly affect the safety or effectiveness of the product that would require submission of a new marketing application. We also note that some of the claims raise jurisdictional issues, and if you intend to continue making such claims, the product may be regulated by the Center for Drug Evaluation and Research (CDER) and subject to drug requirements. Please note that the claims and indications for a product can impact the regulatory pathway of the product, as well as the classification of or jurisdiction of FDA over the product.
The agency previously expressed concerns with the use of XPERIENCE® in deep (surgical) wounds. However, you continue to market XPERIENCE® with the cited claims. For example:
On March 3, 2019, the FDA provided feedback in K203835, Additional Information Letter which stated that the intended use of your device is for use on breached or compromised skin. Any claims regarding the use of the XPERIENCE® product for deep wound cavities, fissures and wound pockets are not cleared under product code FRO (dressing, wound, drug), and require submission of a 510(k) for FDA review.
(b)(4)
to conduct an Investigational Device Exemption Study to expand the use of the XPERIENCE® product for the use in colorectal surgical wounds.
(b)(4)
, the FDA communicated our concern regarding the hemocompatibility of XPERIENCE® product, indicating that it is likely hemolytic. The FDA raised concern that hemocompatibility testing or scientific rationale is needed to evaluate the risk of using the XPERIENCE® product in surgical wounds. You have not provided any additional hemocompatibility report and have not been granted clearance for use of XPERIENCE® in deep (surgical) wounds.
BLASTX®
Your BLASTX® product was cleared under K150792 as Next ScienceTM Wound Gel for Over-The-Counter Use with the following indications for use: “Next ScienceTM Wound Gel is indicated for the management of skin abrasions, lacerations, minor irritations, cuts, exit sites and intact skin.” However, based on our inspection and review of your firm’s website, FDA is aware that your firm is marketing this product without clearance or approval for the following uses in your marketing materials and website (https://www.nextscience.com/blastx-wound-gel/), including but not limited to:
“BLASTX® can be applied once daily for up to 30 days.”
“BLASTX® has been shown to suppress inflammation and repair the skin’s barrier function.”
“BLASTX® inactivates matrix Metalloproteases (MMPs), leading to stopping the cytokine cascade. Also, BLASTX® inactivates proteases production by the bacteria, which prevents tissue destruction and inflammation by the same mechanism.”
“Lowers inflammation allowing transition to proliferative stage.”
“BLASTX® Results in Fewer Days with Wounds, Fewer Amputations.”
These claims were not reviewed as part of your premarket notification materials submitted to FDA and are outside the scope of the clearance issued under K150792. These claims also appear to constitute major changes or modifications in the intended use of the product that require submission of a new marketing application. We also note that some of the claims raise jurisdictional issues, and if you intend to continue making such claims, the product may be regulated by CDER. Please note that the claims and indications for a product can impact the regulatory pathway of the product, as well as the classification of or jurisdiction of FDA over the product.
SURGX®
Your SURGX® product was cleared under K163188 as Next Science nonsterile wound gel for Prescription Use and with the following indications for use: “Next Science Wound Gel (Rx) is indicated for the management of wounds such as Stage I-IV pressure ulcers, partial and full thickness wounds, diabetic foot and leg ulcers, post-surgical wounds, first- and second-degree burns, grafted and donor sites.” However, based on our inspection and review of your firm’s website, FDA is aware that your firm is marketing this product without clearance or approval for the following uses in your marketing materials and website, including but not limited to:
“SURGX® Sterile Antimicrobial Gel as sterilized by gamma radiation for one time use.”
“SURGX® is designed to reduce surgical site and post-surgical infections by destroying planktonic and biofilm-encased bacteria within the gel. The proprietary, non-toxic formulation conforms to the postoperative wound to provide proven broad spectrum and sustained effectiveness for up to 5 days.”
These claims were not reviewed as part of your premarket notification materials submitted to FDA and are outside the scope of the clearance issued under K163188. These claims also appear to constitute major changes or modifications in the intended use of the product that require submission of a new marketing application. We also note that some of the claims raise jurisdictional issues, and if you intend to continue making such claims, the product may be regulated by CDER. Please note that the claims and indications for a product can impact the regulatory pathway of the product, as well as the classification of or jurisdiction of FDA over the product.
Additionally, your firm is currently marketing the XPERIENCE®, BLASTX® and SURGX® products as powered by XBIO® Technology. Our inspection and the review of your website (https://www.nextscience.com/) indicates you are making the following claims for XBIO® Technology:
“Since 2012, Next Science has been developing revolutionary material science-based technology that is non-toxic with proven efficacy against bacteria and microorganisms. This technology is called XBIO®.”
“XBIO™ Technology deconstructs biofilm by removing the metal ions holding it together.”
“XBIO Technology takes an innovative approach to solving the problem of bacterial biofilms. The unique, non-toxic technology attacks and deconstructs the structure of the biofilm by removing the metal ions that hold the EPS together. This exposes the bacteria within the biofilm, making them more vulnerable to eradication. Bacteria that are enveloped within the XBIO Technology are then destroyed by the combination of a surfactant and high osmotic imbalance across the bacterial cell wall. XBIO Technology’s broad-spectrum efficacy helps defend from biofilm reformation, reducing the rate of reoccurrence by over 100X. Due to this unique mechanism of action there is no known resistance to XBIO Technology.”
“XBIO gives physicians the transformational technology to help improve surgical outcomes for even their most at-risk patients.”
“Through our anti-biofilm solutions, it is our purpose to help reduce infections and combat the rising problem of antimicrobial resistance.”
“At Next Science, we are leading a paradigm shift with a unique approach to eradicating both biofilm bacteria and planktonic bacteria with our XBIO Technology. XBIO disrupts the biofilm’s extracellular polymeric substance and exposes the bacteria, once protected by the biofilm, leaving it more vulnerable to attack.”
From the review of your marketing material, you claim XBIO® Technology deconstructs biofilm by removing the metal ions holding biofilm together. The claims indicate that XBIO® Technology has effect on biofilm. XPERIENCE®, BLASTX® and SURGX® have not been evaluated for safety and effectiveness against biofilm. As communicated to you during the regulatory meeting held on May 5, 2022, the antimicrobial component found in your 510(k) cleared products are intended to function as a preservative that inhibits growth of microorganisms in the products and claims of effectiveness against biofilm are outside the clearance of XPERIENCE®, BLASTX® and SURGX®. Additionally, the claims found in our inspection and review of your website go beyond the types of claims appropriate for wound dressings and wound washes categorized under the FRO product code. Further, the claims raise jurisdictional issues, and if you intend to continue making such claims, we note that the products may be regulated by CDER and subject to drug requirements.
Quality System Regulation (QSR) Violations
This inspection also revealed that these products are adulterated within the meaning of section 501(h) of the Act, 21 U.S.C. § 351(h), in that the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the current good manufacturing practice requirements of the Quality System regulation found at Title 21, Code of Federal Regulations (CFR), Part 820.
We received your responses dated September 26, 2024, November 21, 2024, and January 15, 2025, concerning our investigator’s observations noted on the Form FDA 483 (FDA 483), List of Inspectional Observations, that was issued to your firm. We address this response below, in relation to each of the noted violations. These violations include, but are not limited to, the following:
1. Failure to establish and maintain procedures for validating the device design to ensure that devices conform to defined user needs and intended uses and include testing of production units under actual or simulated use conditions, and include risk analysis where appropriate, as required by, 21 CFR 820.30(g). Specifically,
a. Your firm did not provide evidence to demonstrate that the design of XPERIENCE® was validated for the uses claimed in the product labeling and marketing material. Design validation activities for XPERIENCE® (MIS Solution FDA 510(k) K203835) were conducted for cleansing and removal of debris, including microorganisms, from external topical wounds, but your firm markets the solution as “cleared for use in a variety of orthopedic surgeries, including arthroplasty, orthopedic trauma, spine, podiatric, and plastics,” areas that may pose a greater risk and potential adverse effects because of the access to blood vessels and bone. Your firm did not conduct additional blood compatibility studies when establishing the biocompatibility assessment of XPERIENCE® that would be relevant for the uses marketed by your firm. Without this information, there are outstanding questions related to hemolysis risks from the use of this product as marketed by your firm.
b. Your firm did not present design validation studies to support the biofilm disruption mechanism of action currently promoted on your products’ labeling and marketing material. Specifically, your firm’s wound gels and irrigation solutions are labeled as “Powered by XBio®.” Your firm’s website explains that XBio® is a proprietary non-toxic technology platform that disrupts the biofilm’s EPS matrix by removing the metal ions holding it together without inhibiting new tissue growth, offers no known opportunity for bacteria resistance, and removes bacteria from the treated surface and defends against biofilm recurrence.
c. Your firm failed to conduct design validation studies to support the website claim that SURGX® provides broad-spectrum efficacy and multi-log reduction within the gel for fungus
C. albicans and A. brasiliensis
.
Your responses indicate that you have opened CAPA 0029 in response to this observation and that the marketing materials were placed on your firm’s website by a marketing associate without going through the formal review and approval process. Your responses indicate that your firm did not intend to plan and promote these products for the uses described above. Your responses also indicate that you have corrected your website and that your firm will review all currently approved marketing materials to verify that there is supporting evidence for each claim and will remove any claims without such evidence. Your responses indicate that you have hired a Director of Marketing with experience related to medical devices. In addition, your responses stated that you have reopened your Risk Management Plan and initiated a comprehensive reevaluation of risk management activities in accordance with ISO 14971 to better evaluate potential harms associated with known conditions of use. Your responses also indicated that you will update your firm’s website to clearly differentiate the use of XBIO® Technology in non-FDA regulated applications. In addition, your January 15, 2025, response indicates that your firm has updated several applicable procedures. However, at this time, the adequacy of your corrections cannot be determined at this time. Your corrections are ongoing, and a follow-up inspection will verify the effectiveness of your corrective actions.
2. Failure to establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, as required by 21 CFR 820.198(a). For example:
Your firm’s procedure QOP-85-03, Customer Complaints, assigns responsibilities and provides a system and instructions for receiving and processing customer complaints relating to the product. This procedure was not adequately established in that:
a. Information collected by your company from February 2022 through January 2023 regarding excessive bleeding caused by XPERIENCE® was not comprehensively evaluated to determine its relationship to the product and to understand the underlying potential mode or mechanism of failure when using the product on breast soft tissue. Specifically, your firm’s Medical Science Liaison Manager informed a clinical site on January 24, 2023, the following about the bleeding reports: “The fluid action coupled with the surfactant and citrates may loosen micro-clots. Moreover, a cleaner space than you usually see with just N/S may make any extant bleeders more obvious. The general approach seems to be to simply slow down and allow those clots to stabilize before commencing aggressive irrigation.” There is no evidence that this information was further investigated to identify failure mode, risk of using the product on breast soft tissue, and any corrective action needed to preclude the bleeding and oozing adverse events.
b. Complaints reporting several events under one report are entered in your complaint system as one complaint, limiting the extent of the investigation to be conducted for each individual case. Specifically, complaints received for XPERIENCE® reporting excessive bleeding did not include the nature and details of each individual case. In addition, data for complaint trending may be artificially lowered by grouping several events under one complaint, for example:
i. Complaint # 00265- a surgeon reported three cases of bleeding he encountered at two different surgery centers.
ii. Complaint # 00266- a surgeon reported two cases of increase in bleeding within the first five minutes after irrigating on capsulectomy cases.
iii. Complaint # 00274- a surgeon reported three cases of oozing and bleeding and one case of hematoma.
iv. Complaint # 00278- a surgeon reported three cases of diffuse bleeding and oozing.
v. Complaint # 00299- a surgeon reported two cases of diffuse bleeding and one hematoma requiring drainage.
Your responses indicate that you have opened CAPA 0033 and that you have updated your complaint handling module to ask whether new information has been received on a previously closed investigation that would warrant further investigation. Your responses also indicate that you have created a new procedure for Issue Impact Assessments QOP 85-05, and that training was conducted. In addition, your responses indicate that a retrospective review of complaints for all product families and new individual complaint events was opened. Also, your January 15, 2025, response indicates that your firm has updated QOP-82-01 to redefine the process, roles, and responsibilities for the act of reviewing publications, articles, literature reviews and opening complaint report records. We cannot determine the adequacy of your corrective actions at this time. A follow-up inspection will need to be conducted to evaluate the adequacy of the implementation and the effectiveness of your corrective actions.
3. Failure to adequately establish and maintain procedures for implementing corrective and preventive action, as required by 21 CFR 820.100(a). Specifically, per your Corrective and Preventive Action procedure QOP-85-004, a reported failure that may pose a significant patient safety risk and/or presents an upward trend of reported events are to be considered sources of corrective and preventive actions. Your firm did not follow this procedure for the XPERIENCE® bleeding complaints in that a CAPA was not opened after receiving at least twenty reports of excessive bleeding after using XPERIENCE® to rinse the breast pocket in breast surgery cases.
Your responses indicate that you have opened CAPA 0036 and determined that the failure occurred because the relevant procedures did not properly trigger CAPA escalation. Your responses indicate that you have modified your procedures and conducted a retrospective review of complaints based on the updated procedures to determine if CAPAs need to be initiated for certain failures. Your January 15, 2025, response indicated that your firm concluded that no new issues required escalation to CAPA when compared against updated Customer Complaints procedure QOP-85-03. Your responses also indicate that you have developed a new procedure QOP-85-05 Issue Impact Assessment in order to have a documented determination for elevation to CAPA. Your responses indicate that the new procedure will require the Issue Impact Assessment be revisited (including CAPA determinations) when failure modes of a similar nature are detected. Your responses also indicate that you have developed a new work instruction that requires the reporting of trending of failure modes for adverse/reportable/IIA events. We cannot determine the adequacy of your corrective actions at this time. A follow-up inspection will need to be conducted to evaluate the implementation and the effectiveness of your corrective actions.
Medical Device Reporting (MDR) Violations
Our inspection also revealed that your firm’s XPERIENCE® solution is misbranded under section 502(t)(2) of the Act, 21 U.S.C. § 352(t)(2), in that your firm failed or refused to furnish material or information respecting the product that is required by or under section 519 of the Act, 21 U.S.C. § 360i, and 21 CFR Part 803 - Medical Device Reporting. Significant violations include, but are not limited to, the following:
Failure to submit a report to FDA no later than 30 calendar days after the day that your firm received or otherwise became aware of information, from any source, that reasonably suggests that a device that your firm markets may have caused or contributed to a death or serious injury, as required by 21 CFR 803.50(a)(1). For example:
a. The information included for Complaint# 0299 reasonably suggests that a patient sustained an injury (hematoma) following the breast reduction surgery involving your firm’s XPERIENCE® solution, which required percutaneous aspiration. There is no information included in the complaint that rules out that your firm’s XPERIENCE® solution may not have caused or contributed to the referenced injury. Further, the information described in the complaint meets the definition of serious injury under 21 CFR 803.3(w) because medical intervention was necessary to preclude permanent impairment of a body function or permanent damage to a body structure. Your firm became aware of the event on January 26, 2023, yet the corresponding MDR# 3012271775-2024-00002 was not received by the FDA until October 31, 2024, exceeding the required 30-calendar-day reporting timeframe.
b. The information included for Complaint# 0276 reasonably suggests that a patient sustained an injury (diffuse bleeding) on one breast pocket during a bilateral breast augmentation procedure involving the application of your firm’s XPERIENCE® solution, which required a saline wash and cauterization of the bleeding tissue to manage the situation. There is no information included in the complaint that rules out that your firm’s XPERIENCE® solution may not have caused or contributed to the referenced injury. Further, the information described in the complaint meets the definition of serious injury under 21 CFR 803.3(w) because medical intervention was necessary to preclude permanent impairment of a body function or permanent damage to a body structure. Your firm became aware of the event on May 12, 2022, yet the corresponding MDR# 3012271775-2024-00004 was not received by the FDA until November 8, 2024, exceeding the required 30-calendar-day reporting timeframe.
We received your responses dated September 26, 2024, November 21, 2024, and January 15, 2025. Your firm’s responses indicate that corrective actions have been taken to address this observation. These actions include streamlining the MDR reporting process by incorporating an MDR decision tree and conducting a retrospective review of XPERIENCE® complaints related to bleeding for MDR reportability. As a result, we acknowledge receipt of six newly identified MDRs. Additionally, your firm has completed a retrospective review of all complaints from the past three years and confirmed that no additional reportable events were identified. Please note that future FDA inspections or regulatory activities will assess the implementation and effectiveness of your corrective actions.
Your firm should take prompt action to address any violations identified in this letter. Failure to adequately address this matter may result in regulatory action being initiated by the FDA without further notice. These actions include, but are not limited to, seizure, injunction, and civil money penalties.
Other federal agencies may take your compliance with the FD&C Act and its implementing regulations into account when considering the award of federal contracts. Additionally, should FDA determine that you have Quality System regulation violations that are reasonably related to premarket approval applications for Class III devices, such devices will not be approved until the violations have been addressed. Should FDA determine that your products or facilities do not meet the requirements of the Act, requests for Certificates to Foreign Governments (CFG) may not be granted.
Please notify this office in writing within fifteen business days from the date you receive this letter of the specific steps your firm has taken to address the noted violations, as well as an explanation of how your firm plans to prevent these violations, or similar violations, from occurring again. Include documentation of the corrections and/or corrective actions (which must address systemic problems) that your firm has taken. If your firm’s planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of those activities. If corrections and/or corrective actions cannot be completed within fifteen business days, state the reason for the delay and the time within which these activities will be completed. Your firm’s response should be comprehensive and address any violations included in this Warning Letter. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration as part of your response.
Your firm’s response should be sent to: Melissa Michurski, Assistant Director at CDRHenforcement@fda.hhs.gov. Please include in the subject line, CMS case # 698114 when replying. If you have any questions about the contents of this letter, please contact: Demetria Lueneburg, Compliance Officer at Demetria.Lueneburg@fda.hhs.gov.
Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your firm’s facility. It is your firm’s responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the Inspectional Observations, FDA 483, issued at the close of the inspection may be symptomatic of serious problems in your firm’s manufacturing and quality management systems. Your firm should investigate and determine the causes of any violations and take prompt actions to address any violations and bring the products into compliance.
Sincerely yours,
/S/
RDML Sean M. Boyd, MPH, USPHS
Director
Office of Regulatory Programs
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Content current as of:
04/01/2025
Regulated Product(s)
Medical Devices