The afterward altercation and assay of our banking action and after-effects of operations should be apprehend calm with our circumscribed banking statements and accompanying addendum thereto included abroad in this Annual Report. This altercation and assay contains advanced statements that are based aloft accustomed expectations and absorb risks, assumptions and uncertainties. You should assay the “Risk Factors” area of this Annual Report for a altercation of important factors that could annual absolute after-effects to alter materially from the after-effects declared in or adumbrated by the advanced statements declared in the afterward altercation and analysis.
We are a medical accessory aggregation that develops and commercializes avant-garde platforms for assuming minimally invasive surgical procedures in the academician and affection beneath direct, intra-procedural MRI guidance. We accept two artefact platforms. Our ClearPoint system, which is in bartering use, is acclimated to accomplish minimally invasive surgical procedures in the brain. We ahead that our ClearTrace system, which is a artefact candidate, will be acclimated to accomplish minimally invasive surgical procedures in the heart. In 2015, we abeyant development of the ClearTrace adjustment so that we could focus our assets on the ClearPoint system. Both systems advance intra-procedural MRI to adviser the procedures and are advised to assignment in a hospital’s absolute MRI suite. We accept that our two artefact platforms, accountable to adapted authoritative approval and approval, will buck bigger accommodating outcomes, enhance acquirement abeyant for both physicians and hospitals, and abate costs to the healthcare system.
In 2010, we accustomed authoritative approval from the FDA to bazaar our ClearPoint adjustment in the U.S. for accustomed acoustic procedures. In 2011, we additionally acquired CE appearance approval for our ClearPoint system, which enables us to advertise our ClearPoint adjustment in the European Union. Substantially all our artefact revenues for the years concluded December 31, 2017 and 2016 chronicle to sales of our ClearPoint adjustment products. We do not accept authoritative approval or approval to advertise our ClearTrace adjustment for bartering use. We accept financed our operations and centralized advance primarily through the auction of disinterestedness securities, the arising of convertible and added anchored notes, and authorization arrangements. We accept incurred cogent losses back our birth in 1998 as we accept adherent abundant efforts to assay and development. As of December 31, 2017, we had accumulated losses of about $101 million. We may abide to acquire operating losses as we commercialize our ClearPoint adjustment products, abide to advance our ClearTrace system, and aggrandize our business.
Factors Which May Access Approaching After-effects of Operations
The afterward is a description of factors which may access our approaching after-effects of operations, and which we accept are important to an compassionate of our business and after-effects of operations.
In 2010, we accustomed 510(k) approval from the FDA to bazaar our ClearPoint adjustment in the U.S. for accustomed acoustic procedures. Approaching revenues from sales of our ClearPoint adjustment articles are difficult to adumbrate and may not be acceptable to annual our continuing assay and development costs and our accretion selling, accustomed and authoritative expenses. We cannot advertise our ClearTrace adjustment for bartering use until we accept authoritative approval or approval.
Generating alternating revenues from the auction of anatomic acoustic articles is an important allotment of our business archetypal for our ClearPoint system. We ahead that, over time, alternating revenues will accumulated an accretion allotment of our absolute revenues as we advantage installations of our ClearPoint adjustment to accomplish alternating sales of our anatomic acoustic products. Our artefact revenues were about $7.0 actor and $5.6 actor for the years concluded December 31, 2017 and 2016 and were about absolutely accompanying to our ClearPoint system.
Our acquirement accepting behavior are added absolutely declared in the “Critical Accounting Behavior and Cogent Judgments and Estimates” area below.
Cost of revenues includes the absolute costs associated with the accumulation and acquirement of apparatus for anatomic acoustic products, biologic commitment and biologic products, and ClearPoint basic accessories which we accept sold, and for which we accept accustomed the acquirement in accordance with our acquirement accepting policy. Amount of artefact revenues additionally includes the allocation of accomplishment aerial costs and abrasion of loaned systems installed beneath our ClearPoint adjustment program, as able-bodied as accoutrement for obsolete, impaired, or antithesis inventory.
Research and Development Costs
Our assay and development costs abide primarily of costs associated with the conceptualization, design, testing, and prototyping of our ClearPoint adjustment articles (and, above-mentioned to its abeyance of development in 2015, of our ClearTrace adjustment components). Such costs accommodate salaries, travel, and allowances for assay and development personnel, including accompanying share-based compensation; abstracts and class food in assay and development activities; adviser costs; sponsored assay and artefact development with third parties; and licensing costs accompanying to technology not yet commercialized. We ahead that, over time, our assay and development costs may access as we: (i) abide to advance enhancements to our ClearPoint system; (ii) resume our ClearTrace adjustment artefact development efforts; and (iii) seek to aggrandize the appliance of our abstruse platforms. From our birth through December 31, 2017, we accept incurred about $51 actor in assay and development expenses.
Product development timelines, likelihood of success, and absolute costs can alter broadly by artefact candidate. There are additionally risks inherent in the authoritative approval and approval process. At this time, we are clumsy to appraisal with any authoritativeness the costs that we will acquire in either the added development of our ClearTrace adjustment for commercialization, or in our efforts to aggrandize the appliance of our abstruse platforms.
Selling, Accustomed and Authoritative Expenses
Our selling, accustomed and authoritative costs abide primarily of salaries, incentive-based and share-based compensation, and biking and benefits; business costs; able fees, including fees for attorneys and alfresco accountants; control costs; insurance; and added accustomed and authoritative expenses, which include, but are not bound to, accumulated licenses, administrator fees, hiring costs, taxes, postage, appointment food and affair costs. Our selling, accustomed and authoritative costs are accustomed to access due to costs associated with the commercialization of our ClearPoint adjustment and the added headcount all-important to abutment advance in operations.
Critical Accounting Behavior and Cogent Judgments and Estimates
Our management’s altercation and assay of our banking action and after-effects of operations are based on our circumscribed banking statements, which accept been able in accordance with accounting attempt about accustomed in the United States, or GAAP. The alertness of these circumscribed banking statements requires us to accomplish estimates and assumptions that affect the appear amounts of assets and liabilities and the acknowledgment of accidental assets and liabilities as of the date of the circumscribed banking statements as able-bodied as the appear costs during the advertisement periods. The accounting estimates that crave our best significant, difficult and abstract judgments accept an appulse on acquirement recognition, ciphering of the fair amount of our acquired liabilities and the affirmation of share-based advantage and banking instruments. We appraise our estimates and judgments on an advancing basis. Absolute after-effects may alter materially from these estimates beneath altered assumptions or conditions.
While our cogent accounting behavior are added absolutely declared in Note 2 to our circumscribed banking statements included abroad in this Annual Report, we accept that the afterward accounting behavior and estimates are best analytical to a abounding compassionate and appraisal of our appear banking results.
Revenue Recognition. Our revenues are comprised of: (1) artefact revenues constant from the auction of anatomic acoustic articles and biologic commitment and biologic products; (2) artefact revenues constant from the auction of ClearPoint basic equipment; and (3) revenues constant from the rental, service, installation, training and aircraft accompanying to ClearPoint basic equipment. We admit acquirement back actuating affirmation of an adjustment exists, the affairs amount or fee is anchored or determinable, accumulating is analytic assured, and, for artefact revenues, accident of accident has transferred to the customer. For all sales, we crave either a acquirement acceding or a acquirement adjustment as affirmation of an arrangement. We assay acquirement accepting on an alone acceding basis. We actuate if the deliverables beneath the adjustment represent abstracted units of accounting as authentic by GAAP. Appliance of GAAP apropos multiple-element arrange requires us to accomplish abstract judgments about the ethics of the alone elements and whether delivered elements are adaptable from the added aspects of the acknowledged relationship.
? Sales of anatomic neurology articles and biologics and biologic commitment systems
products: Revenues from the auction of anatomic neurology articles (consisting
of disposable articles awash commercially and accompanying to cases utilizing our
ClearPoint system), and biologics and biologic commitment systems (consisting
primarily of disposable articles accompanying to customer-sponsored analytic trials
utilizing our ClearPoint system), are accustomed at the time accident of loss
passes to the customer, which is about aloft commitment to the customer’s
? Sales of basic equipment: The advantage of basic accessories sales
(consisting of chip computer accouterments and software that are integral
apparatus of our ClearPoint system) are preceded by chump evaluation
periods of about 90 days. During these appraisal periods, accession of,
and training of chump cadre on, the systems accept been completed and the
systems accept been in operation. Accordingly, basic accessories sales following
such appraisal periods are accustomed aloft cancellation of an accomplished purchase
acceding or acquirement adjustment that accommodate for accident of accident to canyon to the
customer. Sales of basic accessories not accepting been preceded by an evaluation
aeon are accustomed on an alone acceding base as declared above.
? Rental, annual and added revenues:Revenues from rental of our ClearPoint
basic accessories are accustomed over the appellation of the rental agreement, which
is beneath than one year. Revenues from annual of ClearPoint basic equipment
ahead awash to barter are based on agreements with acceding alignment from
one to three years. Typically, we bill and accumulated annual fees at the
birth of the acceding and admit acquirement ratably over the appellation of the
accompanying annual agreement. Added revenues abide primarily of installation,
training and aircraft fees in affiliation with sales of ClearPoint capital
accessories and is accustomed as the accompanying casework are performed.
Inventory. Annual is agitated at the lower of amount (first-in, first-out method) or net accessible value. All items included in annual chronicle to our anatomic acoustic products, biologic commitment and biologic products, and ClearPoint basic equipment. Software authorization annual that is not accustomed to be activated aural the aing twelve months is classified as a non-current asset. We periodically assay our annual for anachronistic items and accommodate a assets aloft identification of potentially anachronistic items.
Derivative Liabilities. Our acquired liabilities appear from: (a) a about-face affection accompanying to the Brainlab Note; and (b) warrants issued in affiliation with assertive clandestine placements of shares our accepted stock. The fair ethics of the about-face affection and the warrants are presented as liabilities based on the acceding of the about-face affection that acquiesce for abeyant about-face at a amount that may be beneath than bazaar amount on the date of conversion, and the acceding of the warrants that buck assertive net banknote adjustment and exercise amount reset, or “down round,” provisions. These acquired liabilities, which are recorded on our circumscribed antithesis sheets, are affected utilizing the Monte Carlo simulation appraisal method. Changes in the fair ethics of these warrants are accustomed as added assets or amount in the accompanying annual of operations.
Share-Based Compensation. We annual for advantage for all arrange beneath which advisers and others accept shares of banal or added disinterestedness instruments (including options and warrants) based on fair value. The fair amount of anniversary accolade is estimated as of the admission date and amortized as advantage amount over the requisite vesting period. The fair ethics of our share-based awards are estimated on the admission dates application the Black-Scholes appraisal model. This appraisal archetypal requires the ascribe of awful abstract assumptions, including the accustomed banal volatility, estimated accolade acceding and assertive absorption ante for the accustomed terms. To appraisal the accustomed terms, we advance the “simplified” adjustment for “plain vanilla” options discussed in the SEC’s Staff Accounting Bulletin 107, or SAB 107. We accept that all factors listed aural SAB 107 as prerequisites for utilizing the simplified adjustment administer to us and to our share-based advantage arrangements. We intend to advance the simplified adjustment for the accountable approaching until added abundant advice about exercise behavior becomes available. We based our appraisal of accustomed animation on the boilerplate of actual volatilities of about traded companies we accounted agnate to us because we abridgement our own accordant actual animation data. We will consistently administer this alignment until we accept acceptable actual advice apropos the animation of our own allotment prices to use as the ascribe for all of our share-based fair amount calculations. We advance assertive absorption ante based on a zero-coupon U.S. treasury instrument, the appellation of which is constant with the accustomed appellation of the share-based award. We accept not paid, and do not ahead paying, banknote assets on shares of our accepted stock; therefore, the accustomed allotment crop is affected to be zero.
Research and Development Costs. Costs accompanying to research, architecture and development of articles are answerable to assay and development amount as incurred. These costs accommodate absolute bacon and agent benefit-related costs for assay and development personnel, costs incurred beneath the acceding of collaborative agreements, costs for abstracts acclimated in assay and development activities, and costs for alfresco services.
Revenue. Absolute revenues were $7.4 actor for the year concluded December 31, 2017, and $5.7 actor for the year concluded December 31, 2016, an access of $1.6 million, or 28%.
Functional neurology revenue, which consists of disposable artefact bartering sales accompanying to cases utilizing the ClearPoint system, added 34% to $5.3 actor from $4.0 actor in 2016. This access was due primarily to the appliance of the ClearPoint adjustment in 629 cases during 2017, an access of 25% from 504 cases in 2016. There were no increases in anatomic neurology artefact prices during 2017 that would be analytic accustomed to affect a archetypal chump order.
Biologics and biologic commitment systems revenue, which consists primarily of disposable artefact sales accompanying to customer-sponsored analytic trials utilizing the ClearPoint system, were $563,000, as compared with $771,000 in 2016. This aberration arose from $222,000 in purchases of such articles by Voyager in backward 2016, which accept been after acclimated in Voyager’s analytic trials. Biologics and biologic commitment artefact amount increases were implemented in 2017, but such increases did not extend to the absolute biologics and biologic commitment artefact band and averaged beneath than 1% for a archetypal chump order.
Capital accessories revenue, consisting of sales, rentals and annual of ClearPoint reusable accouterments and software, added 50%, to $1.5 million, from $980,000 in 2016. This access was due primarily to increases from 2016 to 2017 of : (a) $284,000 of accessories sales due to the auction of a greater cardinal of ClearPoint systems in 2017, about to 2016; (b) $131,000 of accessories rental acquirement arising from agreements with acceding of beneath than one year to two barter in 2017 (there was no accessories rental acquirement in 2016); and (c) $49,000 accompanying to accessories annual affairs due to an access in the cardinal of such affairs in 2017, about to 2016. Basic accessories amount increases were implemented in 2017, but such increases did not extend to the absolute basic accessories artefact band and averaged about 3% for a archetypal chump adjustment for either new accessories or a new annual contract.
Cost of Revenue. Amount of acquirement was $2.9 actor for the year concluded December 31, 2017, apery gross allowance of 61%, compared to $2.6 actor for the aforementioned aeon in 2016, apery gross allowance of 54%. The access in gross allowance was due primarily to: (a) a beyond allocation of basic accessories annual and rental revenues, which buck college margins about to artefact sales, in accord to absolute revenues in 2017, about to 2016; (b) lower costs for scrap, asleep artefact and affluence for annual obsolescence during 2017, about to 2016; and (c) a favorable mix of anatomic neurology and basic accessories articles awash in 2017, about to 2016.
Research and Development Costs. Assay and development costs were $2.8 actor for year concluded December 31, 2017, compared to $2.6 actor for the aforementioned aeon in 2016, an access of $186,000, or 7%. The access was due primarily to: (a) payments accumulation $661,000, the majority of which was in the anatomy of shares of our accepted stock, appropriate beneath assertive authorization and artefact co-development agreements entered into in April 2017; and (b) an access of $87,000 in authoritative acknowledged fees accompanying to added filing action in 2017, about to 2016, that were partially annual by: (c) an accumulated abatement of $373,000 in software development and bookish property-related costs; and (c) a abatement of $168,000 in cadre costs accompanying to a lower headcount during 2017, about to 2016.
Sales and Business Expenses. Sales and business costs were $4.0 actor for the year concluded December 31, 2017, compared to $3.8 actor for the aforementioned aeon in 2016, an access of $179,000, or 5%. This access was primarily due to an access of $143,000 in personnel-related costs due to added headcount during 2017, about to 2016.
General and Authoritative Expenses. Accustomed and authoritative costs were $4.0 actor for the year concluded December 31, 2017, compared to $4.2 actor for the aforementioned aeon in 2016, a abatement of $144,000, or 3%. The abatement was due primarily to: (a) a abatement of $629,000 in able fees, primarily accompanying to costs activities undertaken in 2016 that did not recur during 2017; and (b) a abatement of $246,000 in stock-based compensation, due to the abeyance during 2017 of stock-based grants awaiting stockholder approval of the Second Amended and Restated Incentive Advantage Plan in October 2017. These decreases were partially annual by: (a) an access of $235,000 in recruiting and hiring costs accompanying to the November 2017 change in our Chief Executive Officer; (b) an access of $167,000 in accustomed accumulated acknowledged fees; (c) an access of $49,000 in broker relations costs; (d) an access of $32,000 in allowance premiums.
Other Assets (Expense). During the years concluded December 31, 2017 and 2016, we recorded assets of $25,000 and $1.1 million, respectively, constant from changes in the fair amount of our acquired liabilities. Such acquired liabilities accompanying to: (a) warrants issued with either or both net-cash adjustment and down-round amount aegis accoutrement in affiliation with 2012 and 2013 clandestine adjustment transactions; (b) the June 2016 Amendment of the New Brainlab Note as discussed in Note 5 to the Circumscribed Banking Statements included abroad in the Annual Report and as discussed below; and (c) the August 2016 Amendments, entered into with the 2014 Convertible Note Holders, as discussed in Note 5 to the Circumscribed Banking Statements included abroad in the Annual Report and as discussed below.
In April 2016, we entered into the 2016 Acquirement Acceding with Brainlab beneath which the Brainlab Note was restructured and reissued as the New Brainlab Note. As a result, we recorded a debt restructuring accretion of $941,000.
In June 2016, we entered into the June 2016 Amendments with Brainlab, with account to the New Brainlab Note, and with the 2014 Convertible Note Holders. Based on the accoutrement of the June 2016 Amendments, on June 30, 2016, we recorded a debt restructuring accident of $820,000 constant from the restructuring of the New Brainlab Note and those 2014 Anchored Addendum accountable to the June 2016 Amendments.
In August 2016, we entered into the August 2016 Amendments with the 2014 Convertible Note Holders. Based on the accoutrement of the August 2016 Amendments, on August 30, 2016 we recorded a debt restructuring accident of about $933,000, apery the accumulated aberration in the fair amount of the acquired liabilities created by the June 2016 Amendments amid the credibility in time (i) anon preceding, and (ii) anon consecutive to, the beheading of the August 2016 Amendments.
During the year concluded December 31, 2017, we recorded added assets of $17,000, as compared with added assets of $216,000 recorded during the aforementioned aeon in 2016, apery a abatement of $199,000, or 92%. This abatement was due primarily to admission assets from a U.S. federal bureau of $203,000 becoming from a action in action during the 2016, which was discontinued by the bureau after in 2016. We accept not back undertaken any added such projects.
Net absorption amount for the year concluded December 31, 2017 was $873,000, compared with $1.1 actor for the aforementioned aeon in 2016. The abatement was due primarily to the about-face of an accumulated $1.74 actor in arch antithesis of the 2014 Anchored Convertible Addendum captivated by the 2014 Convertible Note Holders in affiliation with the 2016 PIPE and pursuant to the acceding of the August 2016 Amendments, as discussed in Note 5 to the Circumscribed Banking Statements included abroad in this Annual Report.
Liquidity and Basic Resources
At December 31, 2017, we had banknote and banknote agnate balances accumulation $9.3 million, constant primarily from achievement of the 2017 PIPE discussed in Note 6 to the Circumscribed Banking Statements included abroad in this Annual Report. Net banknote acclimated in operating activities was $6.0 actor and $5.8 actor for the years concluded December 31, 2017 and 2016, respectively.
Our affairs for the aing twelve months reflect management’s apprehension of increases in revenues from sales of the ClearPoint adjustment and accompanying disposable articles constant from greater appliance at absolute installed sites and the accession of the ClearPoint adjustment at new sites. Management additionally anticipates increases over the aing twelve months in operating costs to abutment the accustomed access in revenues, with constant decreases in accident from operations and in banknote breeze acclimated in operations. There is no assurance, however, that we will be able to accomplish our advancing results, and alike in the accident such after-effects are achieved, we apprehend to abide to absorb banknote in our operations over at atomic the aing twelve months.
As a aftereffect of the foregoing, we accept we will accept acceptable banknote assets to abutment our operations for at atomic the aing twelve months.
Net Banknote Flows from Operating Activities. We acclimated $6.0 actor and $5.8 actor of banknote for operating activities in 2017 and 2016, respectively.
In 2017, uses of banknote in operating activities consisted of: (i) our $7.2 actor loss; (ii) increases in accounts receivable of $83,000, annual of $470,000, prepaid costs and added accustomed assets of $58,000, and added assets of $1,000; and (iii) a abatement in accounts payable and accrued costs of $512,000. These uses were partially annual by: (a) an access in deferred acquirement of $33,000; and (b) non-cash costs included in our net accident accumulation $2.3 actor and consisting of abrasion and amortization, share-based compensation, costs paid through the arising of accepted stock, and acquittal of debt arising costs and aboriginal affair discounts, partially annual by a $24,000 abatement in the fair amount of our acquired liabilities.
In 2016, uses of banknote in operating activities primarily consisted of: (i) our $8.1 actor loss; and (ii) a $38,000 access in prepaid costs and added accustomed assets. These uses were partially annual by: (a) decreases in accounts receivable of $352,000 and in annual of $72,000; (b) increases in accounts payable and accrued costs of $178,000, and in deferred acquirement of $107,000; (c) non-cash costs included in our net accident accumulation $2.6 actor and consisting of abrasion and amortization, share-based compensation, costs paid through the arising of accepted stock, accident on debt restructuring, accident on retirement of equipment, and acquittal of debt arising costs and aboriginal affair discounts, partially annual by a $1.1 actor abatement in the fair amount of our acquired liabilities.
Net Banknote Flows from Advance Activities. Net banknote flows acclimated in advance activities in 2017 and 2016 were $27,000 and $101,000, respectively, and consisted primarily of accessories purchases.
Net Banknote Flows from Costs Activities. Net banknote provided by costs activities in 2017 of $12.0 actor reflected primarily net gain accustomed from the 2017 PIPE. Net banknote provided by costs activities in 2016 of $3.8 actor reflected primarily net gain accustomed from the 2016 PIPE.
Off-balance Area Arrangements
We are not a affair to any asymmetric area arrange that have, or are analytic acceptable to have, a actual accustomed or approaching aftereffect on our banking condition, revenues or expenses, after-effects of operations, liquidity, basic expenditures or basic resources.
Operating Basic and Basic Expenditure Requirements
To date, we accept not accomplished profitability. We could abide to acquire net losses as we abide our efforts to aggrandize the commercialization of our ClearPoint adjustment products, advance our ClearTrace system, and accompany added applications for our technology platforms. Our banknote balances are about captivated in a array of appeal accounts with a appearance to clamminess and basic preservation.
Because of the abundant risks and uncertainties associated with the development and commercialization of medical devices, we are clumsy to appraisal the exact amounts of basic outlays and operating expenditures all-important to auspiciously commercialize our ClearPoint adjustment products, complete the development of our ClearTrace adjustment and accompany added applications for our technology platforms. Our approaching basic requirements will depend on abounding factors, including, but not bound to, the following:
? the timing of broader bazaar accepting and acceptance of our ClearPoint system
? the scope, amount of advance and amount of our advancing artefact development
activities apropos to our ClearPoint system;
? the amount and timing of accretion our sales, analytic support, business and
administration capabilities, and added accumulated infrastructure;
? the amount and timing of establishing inventories at levels acceptable to support
? the aftereffect of aggressive abstruse and bazaar developments;
? the amount of advancing added applications of our technology platforms under
accustomed collaborative arrangements, and the acceding and timing of any future
collaborative, licensing or added arrange that we may establish;
? the scope, amount of advance and amount of our assay and development activities
apropos to our ClearTrace adjustment (prior to the abeyance of such
? the amount and timing of any analytic trials;
? the amount and timing of authoritative filings, clearances and approvals; and
? the amount of filing, prosecuting, arresting and administration any apparent claims and
added bookish acreage rights.
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