7 unchanged sentences
CMS recently released the proposed Outpatient Prospective Payment System (or “OPPS”), for 2024, which did not address our March 2023 submission requesting assignment to one of the New Technology APC payment codes for 2024.
−Removed: We plan to submit formal comments on the proposed OPPS package and advocate for inclusion in the 2024 final rule to be released later this year.
−Removed: While we intend to request that Barostim be reclassified into a higher Medicare reimbursement level, there can be no assurance that such efforts will be successful.
+Added: We submitted formal comments on the proposed OPPS package to advocate for inclusion in the 2024 final rule to be released later this year.
+Added: In August 2023, we delivered a presentation before the CMS Advisory Panel on Hospital Outpatient Payment, resulting in a unanimous non-binding vote in favor of mapping Barostim to the higher paying code, New Technology APC1580, which would offer an average reimbursement of $45,000 to hospitals in 2024.
+Added: If CMS instead decides to map Barostim to APC5465 without the transitional passthrough payment for 2024, which is the basis for our plans, then the average reimbursement to hospitals will be approximately $30,000.
+Added: The final outpatient payment rule is expected to be published in late November.
+Added: There can be no assurance that our efforts to request the higher paying code or the CMS Advisory Panel’s vote will be successful in securing the higher paying code.
Any future decline in the amount Medicare is willing to reimburse our customers for procedures using Barostim could make it difficult for new customers to adopt Barostim and could create additional pricing pressure for us, which could adversely affect our ability to invest in and grow our business.
33 unchanged sentences
and the EEA, comparable regulatory authorities of additional foreign countries must also approve the manufacturing and marketing of our products in those countries.
−Removed: Approval procedures vary among jurisdictions and can involve requirements and administrative review periods different from, and greater than, those in the U.S.
+Added: Approval procedures vary among jurisdictions and can involve requirements and administrative review
+Added: periods different from, and greater than, those in the U.S.
or the EEA, including additional preclinical studies or clinical trials.
4 unchanged sentences
To demonstrate compliance with the Essential Requirements and obtain the right to affix the CE Mark to Barostim, we underwent a conformity assessment procedure, which varied according to the type of medical device and its classification.
−Removed: Except for low-risk medical devices (Class I with no measuring function and which are not sterile), where the manufacturer could issue an EU
−Removed: Declaration of Conformity based on a self-assessment of the conformity of its products with the Essential Requirements, a conformity assessment procedure required the intervention of a Notified Body, which is an organization designated by a competent authority of an EEA country to conduct conformity assessments.
+Added: Except for low-risk medical devices (Class I with no measuring function and which are not sterile), where the manufacturer could issue an EU Declaration of Conformity based on a self-assessment of the conformity of its products with the Essential Requirements, a conformity assessment procedure required the intervention of a Notified Body, which is an organization designated by a competent authority of an EEA country to conduct conformity assessments.
Depending on the relevant conformity assessment procedure, the Notified Body would audit the Quality Management System and examine the Technical File for the manufacture, design, and final inspection of our devices.
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Failing to continue to comply with applicable foreign regulatory requirements, including those administered by authorities of the EEA countries, could result in enforcement actions against us, including refusal, suspension or withdrawal of our CE Certificates of Conformity by our Notified Body (the National Standards Authority of Ireland, or NSAI), which could impair our ability to market products in the EEA in the future.
−Removed: Unregistered Sales of Equity Securities and Use of Proceeds
+Added: Unregistered Sales of Equity Securities, Use of Proceeds , and Issuer Purchases of Equity Securities
Defaults Upon Senior Securities
2 unchanged sentences
Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.